FDA 510(k) Applications for Medical Device Product Code "KQJ"
(System, Fibrinogen Determination)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K965113 | CRESTAT DIAGNOSTICS, INC. | N-ASSAY TIA FIBRINOGEN TEST KIT | 04/16/1997 |
| K050928 | DADE BEHRING, INC. | DADE THROMBIN REAGENT | 06/29/2005 |
| K251968 | Instrumentation Laboratory (IL) Co. | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | 07/24/2025 |
| K073367 | INSTRUMENTATION LABORATORY CO. | HEMOSIL FIBRINOGEN-C | 12/27/2007 |
| K970189 | PANBIO, INC. | FIF TM | 05/21/1997 |
| K971858 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | 10/09/1997 |
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