Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microdiagnostics, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
209 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011952 | DRUGS OF ABUSE MULTI-TEST STRIP | Microdiagnostics, Inc. | 2001-10-25 | 126 | 0 |
| K991516 | MICRO-STRIP FOR MARIJUANA METABOLITES | Microdiagnostics, Inc. | 1999-08-05 | 97 | 0 |
| K991505 | MICRO-STRIP FOR PHENCYCLIDINE METABOLITES | Microdiagnostics, Inc. | 1999-08-05 | 98 | 0 |
| K981388 | MICRO-STRIP FOR COCAINE METABOLITES | Microdiagnostics, Inc. | 1998-05-29 | 43 | 0 |
| K974611 | MICRO-STRIP FOR AMPHETAMINE METABOLITES | Microdiagnostics, Inc. | 1998-03-20 | 99 | 0 |
| K973761 | MICRO-STRIP FOR OPIATE METABOLITES | Microdiagnostics, Inc. | 1997-12-24 | 83 | 0 |
| K932304 | MICRO EIA FOR AMPHETAMINE METABOLITES | Microdiagnostics, Inc. | 1993-12-07 | 209 | 0 |
| K923468 | MICRO EIA FOR OPIATE METABOLITES | Microdiagnostics, Inc. | 1992-09-15 | 63 | 0 |
| K914533 | MICRO EIA FOR COCAINE METABOLITES | Microdiagnostics, Inc. | 1991-12-10 | 60 | 0 |
| K914490 | MICRO EIA FOR MARIJUANA METABOLITES | Microdiagnostics, Inc. | 1991-11-29 | 52 | 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