CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT— 510(k) K915235

Name: FDA 510(k) clearance K915235
Creator: U.S. Food and Drug Administration
Published: 1992-01-28

Substantially Equivalent

Incstar Corp.

FDA 510(k) clearance K915235 for CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT, Substantially Equivalent on 1992-01-28. Applicant: Incstar Corp.. Device class: 2.

Clearance details

Applicant: Incstar Corp.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1991-11-22
Decision date: 1992-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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