FDA applicant

Careside Hemotology, Inc.

Culver City, CA1 decision2002–20020 recalls

FDA records 1 decision for Careside Hemotology, Inc. (Culver City, CA) in 2002: 1 510(k) clearance. All are in product code GFO (Activated Partial Thromboplastin). Its devices cite 2 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Careside Hemotology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Careside”

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

Careside, Inc. 22

Careside Hemotology, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Careside”