Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocell Laboratories, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
81 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000056 | BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS | Biocell Laboratories, Inc. | 2000-02-24 | 48 | 0 |
| K963551 | BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 | Biocell Laboratories, Inc. | 1996-10-07 | 32 | 0 |
| K951749 | BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 | Biocell Laboratories, Inc. | 1995-05-15 | 28 | 0 |
| K844344 | GEMCAL ENI REFERENCE SERUM | Biocell Laboratories, Inc. | 1985-01-03 | 55 | 0 |
| K830911 | RADIAL IMMUNODIFFUSION PLATES | Biocell Laboratories, Inc. | 1983-06-10 | 81 | 0 |
| K830179 | BIOCELL SPINAL FLUID CONTROL | Biocell Laboratories, Inc. | 1983-02-18 | 31 | 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