Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GGP — Predicate Candidate Screening
190 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
227 days90th percentile
190clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | 2025-08-25 | 108 | 0 |
| K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | 2023-12-13 | 260 | 0 |
| K220728 | vWF Ag | Siemens Healthcare Diagnostics Products GmbH | 2023-06-02 | 445 | 0 |
| K214002 | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | 2022-12-23 | 367 | 0 |
| K223402 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | 2022-12-09 | 30 | 0 |
| K200033 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | 2020-08-19 | 225 | 0 |
| K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | 2020-07-17 | 240 | 0 |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. | 2019-03-12 | 90 | 0 |
| K181525 | INNOVANCE Free PS Ag | Siemens Healthcare Diagnostics Products GmbH | 2018-09-07 | 88 | 0 |
| K133005 | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY | Instrumentation Laboratory CO | 2014-03-13 | 169 | 0 |
| K102164 | HEMOSIL PROTEIN S ACTIVITY ASSAY | Instrumentation Laboratory CO | 2011-03-17 | 227 | 0 |
| K092170 | STA LIATEST FREE PS | Diagnostica Stago, Inc. | 2009-12-22 | 154 | 0 |
| K082631 | THROMBO TEK PSE, MODEL 90-480 | R2 Diagnostics, Inc. | 2008-12-17 | 98 | 0 |
| K082205 | FACTOR VIII ANTIBODY SCREEN | Genetic Testing Institute | 2008-11-20 | 107 | 0 |
| K063323 | SPECTROLYSE PAI-1, MODEL 101201 | American Diagnostica, Inc. | 2007-08-15 | 285 | 2 |
| K070635 | HEMOSIL PROCLOT | Instrumentation Laboratory CO | 2007-03-29 | 22 | 0 |
| K062530 | TRIAGE PROTEIN C TEST | Biosite Incorporated | 2007-01-29 | 153 | 0 |
| K062430 | HEMOSIL PROTEIN C | Instrumentation Laboratory CO | 2006-09-01 | 11 | 0 |
| K052825 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | Affinity Biologicals, Inc. | 2006-01-20 | 107 | 0 |
| K053499 | HEMOSIL PROS | Instrumentation Laboratory CO | 2006-01-13 | 28 | 0 |
| K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 | Hyphen Biomed | 2005-12-27 | 316 | 1 |
| K050448 | CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 | Horiba Abx | 2005-09-23 | 213 | 0 |
| K051054 | VISULIZE FACTOR IX ANTIGEN KIT | Affinity Biologicals, Inc. | 2005-06-29 | 64 | 0 |
| K043571 | CRYOCHECK CLOT S | Precision Biologic, Inc. | 2005-03-18 | 81 | 0 |
| K042576 | COATEST SP FVIII | Instrumentation Laboratory CO | 2004-12-02 | 71 | 0 |
| K040987 | CRYOCHECK CLOT C | Precision Biologic, Inc. | 2004-06-18 | 64 | 0 |
| K040843 | HEMOSIL VON WILLEBRAND ACTIVITY | Instrumentation Laboratory CO | 2004-04-30 | 29 | 1 |
| K032139 | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 | Corgenix, Inc. | 2004-04-05 | 269 | 0 |
| K033631 | MODIFICATION TO COATEST FACTOR VIII | Instrumentation Laboratory CO | 2003-12-15 | 26 | 0 |
| K023990 | CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 | Precision Biologic | 2003-03-19 | 106 | 0 |
| K022290 | PROTEIN S AC | Dade Behring, Inc. | 2002-08-27 | 43 | 0 |
| K013492 | IMUBIND TPA ELISA, MODEL 860 | American Diagnostica, Inc. | 2002-03-13 | 142 | 0 |
| K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 | American Diagnostica, Inc. | 2002-03-07 | 167 | 1 |
| K012386 | ACTICLOT PROTEIN S, MODEL 843L | American Diagnostica, Inc. | 2001-09-14 | 49 | 0 |
| K011424 | IL TEST PROS | Instrumentation Laboratory CO | 2001-06-25 | 47 | 0 |
| K010963 | STA-LIATEST FREE PROTEIN S TEST KIT | Diagnostica Stago, Inc. | 2001-06-06 | 68 | 1 |
| K010379 | IL TEST FREE PROTEIN S | Instrumentation Laboratory CO | 2001-04-13 | 64 | 0 |
| K002467 | COALIZA PROTEIN S-FREE | Instrumentation Laboratory CO | 2000-10-13 | 63 | 0 |
| K002350 | REFACTO LABORATORY STANDARD | The Genetics Institute | 2000-10-05 | 64 | 0 |
| K002541 | PROTEIN C REAGENT | Dade Behring, Inc. | 2000-09-26 | 41 | 0 |
| K000649 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | 2000-04-25 | 57 | 0 |
| K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 | Shield Diagnostics, Ltd. | 2000-04-17 | 70 | 0 |
| K993553 | GTI-FVIII INHIBITOR ASSAY | Genetic Testing Institute | 2000-02-01 | 104 | 0 |
| K992704 | IL TEST VON WILLEBRAND FACTOR | Instrumentation Laboratory CO | 1999-11-01 | 81 | 0 |
| K983898 | BIOCLOT APC SENSITIVITY | Biopool Intl., Inc. | 1999-01-06 | 64 | 0 |
| K983914 | REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT | Corgenix, Inc. | 1998-12-22 | 48 | 0 |
| K983107 | VFE | Ramco Laboratories, Inc. | 1998-10-22 | 48 | 0 |
| K981817 | COAMATIC PLASMIN INHIBITOR | Instrumentation Laboratory CO | 1998-09-28 | 129 | 0 |
| K981696 | IL TEST PLASMIN INHIBITOR | Instrumentation Laboratory CO | 1998-08-27 | 105 | 0 |
| K980885 | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY | Shield Diagnostics, Ltd. | 1998-08-21 | 165 | 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