Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GJA · Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
256 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050817 | T-TEK | R2 Diagnostics, Inc. | 2005-12-12 | 256 | 0 |
| K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | Sigma Diagnostics, Inc. | 1998-10-15 | 114 | 0 |
| K970645 | BC THROMBIN REAGENT | Behring Diagnostics, Inc. | 1997-05-19 | 88 | 1 |
| K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | Biomerieux Vitek, Inc. | 1994-04-21 | 535 | 0 |
| K930157 | TEST THROMBIN | Behring Diagnostics, Inc. | 1993-05-14 | 121 | 0 |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | Medical Laboratory Automation Systems, Inc. | 1992-09-29 | 90 | 0 |
| K920147 | THROMBIN CLOTTING TIME REAGENT | Helena Laboratories | 1992-05-01 | 109 | 0 |
| K900126 | TT AND HNTT BY HEMOCHRON | International Technidyne Corp. | 1990-02-05 | 27 | 0 |
| K894467 | THROMBIN TIME REAGENT | Sigma Chemical Co. | 1989-09-05 | 49 | 0 |
| K884385 | FIBRI-PREST/THROMBIN-PREST CONTROLS | American Bioproducts Co. | 1988-12-28 | 71 | 0 |
| K884384 | THROMBIN-PREST REAGENT KIT | American Bioproducts Co. | 1988-12-28 | 71 | 0 |
| K862301 | IL SYSTEM 810, ACL AND THE REAGENT SETS | Instrumentation Laboratory CO | 1986-09-03 | 78 | 0 |
| K845000 | THROMBINEX BOVINE THROMBIN | Bio/Data Corp. | 1985-03-26 | 90 | 0 |
| K841956 | BOVINE THROMBIN, HUMAN THROMBIN | Haemachem, Inc. | 1984-07-19 | 66 | 0 |
| K834301 | THROMBOLYTIC ACTIVITY TEST | Bio/Data Corp. | 1984-02-04 | 57 | 0 |
| K822466 | THROMBIN TIME TEST | American Dade | 1982-09-14 | 29 | 0 |
| K811109 | THROMBIN CLOTTING TIME | Bio/Data Corp. | 1981-07-16 | 84 | 0 |
| K802117 | FIBRI QUIK | General Diagnostics | 1980-09-26 | 22 | 1 |
| K800926 | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | General Diagnostics | 1980-05-08 | 17 | 0 |
| K781781 | HEPARSORB | General Diagnostics | 1979-01-10 | 83 | 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