Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro Detect, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
112 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003794 | ELISA TEST, SEROLOGY | Micro Detect, Inc. | 2001-03-30 | 112 | 0 |
| K002358 | MDI GLIADIN A TEST | Micro Detect, Inc. | 2000-10-19 | 78 | 0 |
| K002359 | MDI GLIADIN G TEST | Micro Detect, Inc. | 2000-10-19 | 78 | 0 |
| K000934 | MDI SCL-70 TEST | Micro Detect, Inc. | 2000-04-07 | 15 | 0 |
| K000477 | MDI DS-DNA TEST | Micro Detect, Inc. | 2000-03-01 | 16 | 0 |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOAN | Micro Detect, Inc. | 2000-01-11 | 49 | 0 |
| K994029 | MDI SM TEST | Micro Detect, Inc. | 2000-01-11 | 46 | 0 |
| K993843 | MDI RF TEST | Micro Detect, Inc. | 2000-01-11 | 60 | 0 |
| K993635 | MDI SM/RNP TEST | Micro Detect, Inc. | 2000-01-10 | 75 | 0 |
| K993636 | MDI SS-A TEST | Micro Detect, Inc. | 2000-01-10 | 75 | 0 |
| K973508 | PYLORI DETECT IGG | Micro Detect, Inc. | 1998-03-10 | 175 | 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