PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT— 510(k) K862336

Name: FDA 510(k) clearance K862336
Creator: U.S. Food and Drug Administration
Published: 1986-09-25

Substantially Equivalent

Pantex, Div. Bio-Analysis, Inc.

FDA 510(k) clearance K862336 for PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1986-09-25. Applicant: Pantex, Div. Bio-Analysis, Inc.. Device class: 2.

Clearance details

Applicant: Pantex, Div. Bio-Analysis, Inc.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1986-06-20
Decision date: 1986-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

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