Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nolan Biological Laboratories, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
53 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K812741 | REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS | Nolan Biological Laboratories, Inc. | 1981-10-23 | 24 | 0 |
| K812740 | REAGENTS FOR SERODIAGNOSIS OF ASPERGILL | Nolan Biological Laboratories, Inc. | 1981-10-20 | 21 | 0 |
| K802129 | IMMUNODIFFUSION REAGENTS/SEROLOGICAL | Nolan Biological Laboratories, Inc. | 1980-09-26 | 53 | 0 |
| K802130 | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | Nolan Biological Laboratories, Inc. | 1980-09-26 | 53 | 0 |
| K802128 | IMMUNODIFFUSSION REAGENTS/SEROLOGICAL | Nolan Biological Laboratories, Inc. | 1980-09-26 | 53 | 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