KQJ — System, Fibrinogen Determination Class II
FDA product code KQJ covers "System, Fibrinogen Determination", a Class II medical device regulated under 21 CFR 864.7340. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KQJ
- Device Class
- Class II
- Regulation Number
- 864.7340
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251968 | instrumentation laboratory (il) | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | July 24, 2025 |
| K073367 | instrumentation laboratory | HEMOSIL FIBRINOGEN-C | December 27, 2007 |
| K050928 | dade behring | DADE THROMBIN REAGENT | June 29, 2005 |
| K971858 | sigma diagnostics | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | October 9, 1997 |
| K970189 | panbio | FIF TM | May 21, 1997 |
| K965113 | crestat diagnostics | N-ASSAY TIA FIBRINOGEN TEST KIT | April 16, 1997 |
| K934326 | behring diagnostics | MULTIFIBREN U | April 19, 1994 |
| K931721 | instrumentation laboratory | IL TEST FIBRINOGEN-C | August 13, 1993 |
| K922416 | binding site | FIBRINOGEN RID TEST KIT | March 9, 1993 |
| K925988 | behring diagnostics | MULTIFIBREN | March 1, 1993 |
| K923593 | international technidyne | HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS | September 22, 1992 |
| K920258 | bd becton dickinson vacutainer systems preanalytic | QBC FIBRINOGEN | June 26, 1992 |
| K900939 | incstar | SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) | May 16, 1990 |
| K900895 | organon teknika | COAG-A-MATE - RA4 | April 16, 1990 |
| K896052 | medical diagnostic technologies | FIBRINOGEN ASSAY KIT | November 9, 1989 |
| K884179 | unipath | TURBOX FIBRINOGEN | December 20, 1988 |
| K841366 | diatech | DIA FIBRIN | June 1, 1984 |
| K841020 | helena laboratories | FIBRINOGEN ASSAY KIT | May 2, 1984 |
| K840211 | wellcome diagnostics | FIBRI-PREST AUTOMATE HA34 | March 2, 1984 |
| K834571 | diatech | FIBRINOGEN TEST | February 4, 1984 |