FDA applicant

Sclavo, Inc.

Wayne, NJ82 decisions1977–19920 recalls

FDA records 82 decisions for Sclavo, Inc. (Wayne, NJ) from 1977 to 1992: 82 510(k) clearances. Most are in product codes CHH (Enzymatic Esterase--Oxidase, Cholesterol) and CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes). 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 Sclavo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sclavo, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Sclavo, Inc.

Which product codes does it file in?

What has FDA decided for it lately?