Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GIR — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
162 daysmedian FDA review time
426 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132076 | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | Dsrv, Inc. | 2014-01-10 | 191 | 0 |
| K132130 | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | Dsrv, Inc. | 2014-01-10 | 184 | 0 |
| K110031 | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | Instrumentation Laboratory CO | 2011-08-24 | 231 | 0 |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | R2 Diagnostics, Inc. | 2010-06-25 | 543 | 0 |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Diagnostica Stago, Inc. | 2006-12-06 | 162 | 0 |
| K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | Sigma Diagnostics, Inc. | 2000-04-07 | 50 | 0 |
| K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | Sigma Diagnostics, Inc. | 2000-04-07 | 50 | 0 |
| K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 | Precision Biologic | 1999-07-28 | 155 | 0 |
| K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 ( | Precision Biologic | 1999-07-23 | 150 | 0 |
| K990302 | IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC | Instrumentation Laboratory CO | 1999-04-08 | 66 | 0 |
| K940490 | DV TEST AND DVV CONFIRM | American Diagnostica, Inc. | 1995-04-05 | 426 | 0 |
| K932463 | BIOCLOT LA | Biopool AB | 1993-09-27 | 129 | 0 |
| K922326 | LUPO-TEST REGEANT | Graoipore , Ltd. | 1993-04-06 | 330 | 0 |
| K922156 | LUCOR CONFIRMATORY REAGENT | Gradipore , Ltd. | 1993-04-06 | 334 | 0 |
| K903037 | LUPO-TEST REAGENT | Gradipore , Ltd. | 1990-12-17 | 159 | 0 |
| K841365 | DIA REPTIN | Diatech, Inc. | 1984-06-01 | 60 | 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