510(k) Report

FDA applicant

Careside, Inc.

Culver City, CA22 decisions1998–20020 recalls

FDA records 22 decisions for Careside, Inc. (Culver City, CA) from 1998 to 2002: 22 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and JHS (Differential Rate Kinetic Method, Cpk Or…). Its devices cite 23 predicates, 0 of them its own earlier devices. 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 Careside, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Careside, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Careside, 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 “Careside”

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