Product code JJE: 510(k) clearances and predicates
Product code JJE covers Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode. FDA lists 208 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
208 clearances on file under product code JJE. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JJE clearances in the FDA index, with applicant and decision date:
- K183375, Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode, applicant Horiba, Ltd., decided 2019-02-12. FDA record
- K133519, CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR, applicant Carolina Liquid Chemistries Corp., decided 2014-05-16. FDA record
- K130915, XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK, applicant Jas Diagnostics, Inc., decided 2014-05-15. FDA record
- K131554, RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT, applicant Randox Laboratories, Ltd., decided 2014-01-09. FDA record
- K130276, DIMENSION EXL WITH LM SYSTEM, applicant Siemens Healthcare Diagnostics, Inc., decided 2013-03-22. FDA record
- K113253, ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT, applicant Alfa Wassermann Diagnostic Technologies, Inc., decided 2012-05-17. FDA record
- K112999, DIMENSION CLINICAL CHEMISTRY SYSTEM, applicant Siemens Healthcare Diagnostics, decided 2011-11-22. FDA record
- K110035, INDIKO, applicant Thermofisher Scientific OY, decided 2011-06-28. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR, XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK. Watch new JJE clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JJE?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JJE clearances include Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode.
How many 510(k) clearances use product code JJE?
208 at the time this page was generated, from openFDA records.
How do I find a predicate device under JJE?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JJE clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.