FDA product code KQJ: System, Fibrinogen Determination
KQJ is the FDA product code for system, fibrinogen determination. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel. FDA has cleared 28 510(k) submissions under KQJ, 1 in the last five years, from 24 different applicants. The average 510(k) review took 80 days (median 60); 28 days on average over the last three years. FDA has posted 3 recalls for KQJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Fibrinogen Determination |
| Device class | Class II |
| Regulation | 21 CFR 864.7340 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KQJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 28 |
Compare with all 510(k) review times · Search every KQJ clearance
Top KQJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 2 | 2007-12-27 |
| Behring Diagnostics, Inc. | 2 | 1994-04-19 |
| Diatech, Inc. | 2 | 1984-06-01 |
| Bio/Data Corp. | 2 | 1981-09-24 |
| Instrumentation Laboratory (IL) Co. | 1 | 2025-07-24 |
19 more applicants have KQJ clearances. See the full list in Caduvo.
Most recent KQJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251968 | Instrumentation Laboratory (IL) Co. | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | 2025-07-24 | 28 |
| K073367 | Instrumentation Laboratory CO | HEMOSIL FIBRINOGEN-C | 2007-12-27 | 27 |
| K050928 | Dade Behring, Inc. | DADE THROMBIN REAGENT | 2005-06-29 | 76 |
| K971858 | Sigma Diagnostics, Inc. | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | 1997-10-09 | 142 |
| K970189 | Panbio, Inc. | FIF TM | 1997-05-21 | 120 |
Recalls for KQJ devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-07-21.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KQJ?
KQJ is the FDA product code for system, fibrinogen determination. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel.
What device class is KQJ?
Class II, regulation 21 CFR 864.7340. Typical premarket route: 510(k).
How long does a 510(k) take for product code KQJ?
Across 28 cleared submissions the average was 80 days from receipt to decision (median 60).
Which companies have the most KQJ clearances?
Instrumentation Laboratory CO (2); Behring Diagnostics, Inc. (2); Diatech, Inc. (2); Bio/Data Corp. (2); Instrumentation Laboratory (IL) Co. (1).
Have KQJ devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2025-07-21.
Next steps
- Run an FDA pathway report with predicate devices for product code KQJ
- Run a recall and safety report across every KQJ manufacturer
- Watch product code KQJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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