Product code JJY: 510(k) clearances and predicates
Product code JJY covers Audit MicroControls Linearity FD Tumor Markers II. FDA lists 673 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
673 clearances on file under product code JJY. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JJY clearances in the FDA index, with applicant and decision date:
- K162530, Multichem IA Plus, applicant Techno-Path Manufacturing, decided 2017-03-31. FDA record
- K163629, Audit MicroControls Linearity FD Tumor Markers II, applicant Aalto Scientific, Ltd., decided 2017-03-10. FDA record
- K163015, Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak, applicant Bio-Rad Laboratories, decided 2017-01-10. FDA record
- K153712, VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit, applicant Radiometer America, Inc., decided 2016-01-28. FDA record
- K150300, Liquichek Cardiac Markers Plus Control LT, applicant Bio-Rad Laboratories, decided 2015-12-11. FDA record
- K142964, VALIDATE Anemia Calibration Verification/ Linearity Test Kit, applicant Maine Standards Company, LLC, decided 2015-04-30. FDA record
- K143379, Liquichek Maternal Serum II Control, applicant Bio-Rad Laboratories, decided 2015-03-13. FDA record
- K143573, Audit MicroControls Linearity FD Tumor Markers II, applicant Aalto Scientific, Ltd., decided 2015-01-16. 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 Multichem IA Plus, Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak. Watch new JJY 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 JJY?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JJY clearances include Audit MicroControls Linearity FD Tumor Markers II.
How many 510(k) clearances use product code JJY?
673 at the time this page was generated, from openFDA records.
How do I find a predicate device under JJY?
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 JJY clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.