GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT— 510(k) K915570

Name: FDA 510(k) clearance K915570
Creator: U.S. Food and Drug Administration
Published: 1992-01-27

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K915570 for GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1992-01-27. Applicant: Incstar Corp.. Device class: 1.

Clearance details

Applicant: Incstar Corp.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1991-12-12
Decision date: 1992-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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