Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KQJ — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
60 daysmedian FDA review time
157 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | 2025-07-24 | 28 | 0 |
| K073367 | HEMOSIL FIBRINOGEN-C | Instrumentation Laboratory CO | 2007-12-27 | 27 | 0 |
| K050928 | DADE THROMBIN REAGENT | Dade Behring, Inc. | 2005-06-29 | 76 | 0 |
| K971858 | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | Sigma Diagnostics, Inc. | 1997-10-09 | 142 | 0 |
| K970189 | FIF TM | Panbio, Inc. | 1997-05-21 | 120 | 0 |
| K965113 | N-ASSAY TIA FIBRINOGEN TEST KIT | Crestat Diagnostics, Inc. | 1997-04-16 | 117 | 0 |
| K934326 | MULTIFIBREN U | Behring Diagnostics, Inc. | 1994-04-19 | 228 | 0 |
| K931721 | IL TEST FIBRINOGEN-C | Instrumentation Laboratory CO | 1993-08-13 | 128 | 0 |
| K922416 | FIBRINOGEN RID TEST KIT | The Binding Site, Ltd. | 1993-03-09 | 292 | 0 |
| K925988 | MULTIFIBREN | Behring Diagnostics, Inc. | 1993-03-01 | 96 | 0 |
| K923593 | HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS | International Technidyne Corp. | 1992-09-22 | 64 | 0 |
| K920258 | QBC FIBRINOGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-06-26 | 157 | 0 |
| K900939 | SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) | Incstar Corp. | 1990-05-16 | 77 | 0 |
| K900895 | COAG-A-MATE - RA4 | Organon Teknika Corp. | 1990-04-16 | 48 | 0 |
| K896052 | FIBRINOGEN ASSAY KIT | Medical Diagnostic Technologies, Inc. | 1989-11-09 | 22 | 0 |
| K884179 | TURBOX FIBRINOGEN | Unipath , Ltd. | 1988-12-20 | 81 | 0 |
| K841366 | DIA FIBRIN | Diatech, Inc. | 1984-06-01 | 60 | 0 |
| K841020 | FIBRINOGEN ASSAY KIT | Helena Laboratories | 1984-05-02 | 51 | 0 |
| K840211 | FIBRI-PREST AUTOMATE HA34 | Wellcome Diagnostics | 1984-03-02 | 43 | 1 |
| K834571 | FIBRINOGEN TEST | Diatech, Inc. | 1984-02-04 | 37 | 0 |
| K812629 | ACA FIBRINOGEN TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1981-10-08 | 24 | 0 |
| K812570 | LABCER FIBRINOGEN ASSAY KIT & CALIBR. | Sherwood Medical Co. | 1981-10-02 | 23 | 0 |
| K812108 | LOW FIBRINOGEN CONTROL | Bio/Data Corp. | 1981-09-24 | 59 | 0 |
| K811069 | FIBRINOGEN CONTROL PLASMA | American Dade | 1981-07-10 | 81 | 0 |
| K810058 | ORTHO QUANTITATIVE FIBRINOGEN ASSAY | Ortho Diagnostic Systems, Inc. | 1981-02-26 | 44 | 0 |
| K801926 | SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA | Sigma Chemical Co. | 1980-09-09 | 28 | 0 |
| K800826 | FIBRINOGEN SCREEN | Pacific Hemostasis | 1980-05-30 | 46 | 0 |
| K792563 | THROMBOKINETIC FIBRINOGEN ASSAY | Bio/Data Corp. | 1980-01-11 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda