Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clin Tech Diagnostics Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
56 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821969 | ACETAMINOPHEN STAT-PAK REAGENT SET | Clin Tech Diagnostics Corp. | 1982-07-16 | 15 | 0 |
| K820076 | GLYCO-SEP REAGENT TEST SET | Clin Tech Diagnostics Corp. | 1982-02-12 | 31 | 0 |
| K813185 | SALICYLATE STAT-PAK | Clin Tech Diagnostics Corp. | 1981-11-24 | 8 | 0 |
| K810235 | ACETAMINOPHEN/SALICYLATE CONTROL | Clin Tech Diagnostics Corp. | 1981-02-10 | 13 | 0 |
| K802432 | GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. | Clin Tech Diagnostics Corp. | 1980-12-01 | 56 | 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