FDA applicant
Biocell Laboratories, Inc.
FDA records 6 decisions for Biocell Laboratories, Inc. (Rancho Dominguez, CA) from 1983 to 2000: 6 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biocell Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biocell Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biocell Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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