ISOENZYME TEST CK-MB— 510(k) K850212

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K850212 for ISOENZYME TEST CK-MB, Substantially Equivalent on 1985-02-07. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1985-01-15
Decision date: 1985-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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