510(k) Report

FDA applicant

E-Y Laboratories, Inc.

San Mateo, CA13 decisions1983–19940 recalls

FDA records 13 decisions for E-Y Laboratories, Inc. (San Mateo, CA) from 1983 to 1994: 13 510(k) clearances. Most are in product codes JTO (Discs, Strips And Reagents, Microorganism…) and JSF (Culture Media, Single Biochemical Test). 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 E-Y Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for E-Y Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like E-Y 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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