Product code JJQ: 510(k) clearances and predicates
Product code JJQ covers UBIT-IR300 INFRARED SPECTROMETRY SYSTEM. FDA lists 258 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
258 clearances on file under product code JJQ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest JJQ clearances in the FDA index, with applicant and decision date:
- K013371, UBIT-IR300 INFRARED SPECTROMETRY SYSTEM, applicant Otsuka Pharmaceutical Co., Ltd., decided 2001-12-21. FDA record
- K980120, DIGENE DML 2000 MICROPLATE LUMINOMETER, applicant Digene Corp., decided 1998-02-06. FDA record
- K973938, ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER, applicant Sfri, Inc., decided 1998-02-04. FDA record
- K974762, STAT TRACKS, applicant Awareness Technology, Inc., decided 1998-01-28. FDA record
- K962113, ANTHOS PHACTS VERSION MICROPLATE READER, applicant Columbia Bioscience, Inc., decided 1996-11-05. FDA record
- K961183, CBI 7520 READER, applicant Columbia Bioscience, Inc., decided 1996-08-02. FDA record
- K962166, ORIGEN ANALYZER, applicant Igen, Inc., decided 1996-07-31. FDA record
- K955077, ANTHOS 2010 READER, applicant Anthos Labtec, Inc., decided 1995-12-04. 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 DIGENE DML 2000 MICROPLATE LUMINOMETER, ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER. Watch new JJQ 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 JJQ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JJQ clearances include UBIT-IR300 INFRARED SPECTROMETRY SYSTEM.
How many 510(k) clearances use product code JJQ?
258 at the time this page was generated, from openFDA records.
How do I find a predicate device under JJQ?
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 JJQ 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.