FDA applicant

Cala Diagnostics

Los Osos, CA12 decisions1985–19940 recalls

FDA records 12 decisions for Cala Diagnostics (Los Osos, CA) from 1985 to 1994: 12 510(k) clearances. Most are in product codes JJT (Enzyme Controls (Assayed And Unassayed)) and DKC (Alcohol 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 Cala Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cala Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Cala”

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

Cala Health, Inc. 7

Cala Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Cala”