Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotek Solutions, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
323 daysmedian FDA review time
796 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950148 | CHEMMATE(TM) CD43 | Biotek Solutions, Inc. | 1996-07-02 | 532 | 0 |
| K936111 | CHEMMATE SPECIAL STAIN LCA-CD45 | Biotek Solutions, Inc. | 1996-02-27 | 796 | 0 |
| K950149 | CHEMMATE(TM) LAMBDA | Biotek Solutions, Inc. | 1995-12-06 | 323 | 0 |
| K950152 | CHEMMATE(TM) UCHL1 (CD45-RO) | Biotek Solutions, Inc. | 1995-10-27 | 283 | 0 |
| K950150 | CHEMMATE(TM) KAPPA | Biotek Solutions, Inc. | 1995-10-27 | 283 | 0 |
| K950151 | CHEMMATE(TM) L26 (CD20) | Biotek Solutions, Inc. | 1995-10-04 | 260 | 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