510(k) Report

FDA applicant

Clinical Controls, Inc.

Grover Beach, CA18 decisions1994–20010 recalls

FDA records 18 decisions for Clinical Controls, Inc. (Grover Beach, CA) from 1994 to 2001: 18 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJX (Single (Specified) Analyte Controls (Assayed…). No recall is linked to its devices.

FDA’s records also spell it “Clinical Controls”.

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 Clinical Controls, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Controls, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Clinical Controls, 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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