510(k) Report

FDA applicant

Molecular Biosystems, Inc.

San Diego, CA4 decisions1987–19880 recalls

FDA records 4 decisions for Molecular Biosystems, Inc. (San Diego, CA) from 1987 to 1988: 4 510(k) clearances. Most are in product codes LQO (Dna-Reagents, Campylobacter Spp.) and LGO (Test, Leukocyte Typing). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Molecular Biosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Molecular Biosystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Molecular Biosystems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Molecular Biosystems, 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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Other applicant names beginning “Molecular”

FDA records each applicant name separately; these may or may not be the same firm.