Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GOD — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
174 daysmedian FDA review time
203 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110722 | RPS ADENO DETECTOR PLUS | Rapid Pathogen Screening, Inc. | 2011-05-17 | 63 | 0 |
| K052092 | RPS ADENO DETECTOR | Rapid Pathogen Screening | 2005-11-22 | 112 | 0 |
| K990630 | SAS ADENO TEST | Sa Scientific, Inc. | 1999-08-19 | 174 | 0 |
| K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM | Immunoprobe, Inc. | 1997-12-22 | 179 | 0 |
| K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | Cambridge Bioscience Corp. | 1988-07-08 | 64 | 0 |
| K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST | Cambridge Bioscience Corp. | 1988-02-24 | 203 | 0 |
| K873312 | ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST | Cambridge Bioscience Corp. | 1988-02-24 | 190 | 0 |
| K871229 | ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 | 91 | 0 |
| K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST | Orion Diagnostica, Inc. | 1987-06-04 | 191 | 0 |
| K843649 | ADENOVIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K802929 | ADENO VIRUS & CONTROLS | Orion Diagnostica, Inc. | 1980-12-31 | 42 | 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