FDA applicant

Sc Calibrators & Controls, LLC

Santa Monica, CA3 decisions1997–19980 recalls

FDA records 3 decisions for Sc Calibrators & Controls, LLC (Santa Monica, CA) from 1997 to 1998: 3 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DIF (Drug Mixture Control Materials). 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 Sc Calibrators & Controls, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sc Calibrators & Controls, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Sc Calibrators & Controls, LLC

Which product codes does it file in?

What has FDA decided for it lately?