PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT— 510(k) K862447

Name: FDA 510(k) clearance K862447
Creator: U.S. Food and Drug Administration
Published: 1986-10-07

Substantially Equivalent

Pantex, Div. Bio-Analysis, Inc.

FDA 510(k) clearance K862447 for PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1986-10-07. Applicant: Pantex, Div. Bio-Analysis, Inc.. Device class: 2.

Clearance details

Applicant: Pantex, Div. Bio-Analysis, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1986-06-27
Decision date: 1986-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

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