510(k) Report

FDA applicant

Ocean Scientific, Inc.

Garden Grove, CA6 decisions1984–19890 recalls

FDA records 6 decisions for Ocean Scientific, Inc. (Garden Grove, CA) from 1984 to 1989: 6 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and GMQ (Antigens, Nontreponemal, All). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Ocean Scientific, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ocean Scientific, 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 “Ocean”

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