Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biosan Laboratories, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
220 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860642 | PHOTRON VISUAL FIELD ANALYZER | Biosan Laboratories, Inc. | 1986-04-15 | 54 | 0 |
| K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | Biosan Laboratories, Inc. | 1985-11-01 | 50 | 0 |
| K832763 | TOBRAMYCIN REAGENT | Biosan Laboratories, Inc. | 1984-03-23 | 220 | 0 |
| K833193 | RADIOIMMUNOASSAY, THYROID STIMU. HORMONE | Biosan Laboratories, Inc. | 1984-02-04 | 138 | 0 |
| K834023 | BIO-SCIENCE LABORATORIES T4 REAGENT | Biosan Laboratories, Inc. | 1984-01-24 | 63 | 0 |
| K833318 | NORMAL GOAT SERUM | Biosan Laboratories, Inc. | 1984-01-03 | 99 | 0 |
| K833320 | AMBERLITE CG50 RESIN, 100-200 MESH | Biosan Laboratories, Inc. | 1983-12-08 | 73 | 0 |
| K833192 | NORMAL URINE CONTROL | Biosan Laboratories, Inc. | 1983-12-08 | 80 | 0 |
| K833191 | ABNORMAL URINE CONTROL | Biosan Laboratories, Inc. | 1983-12-08 | 80 | 0 |
| K833319 | BIO-REX 70 RESIN 100-200 MESH PH6.2 | Biosan Laboratories, Inc. | 1983-11-03 | 38 | 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