TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE— 510(k) K883765

Name: FDA 510(k) clearance K883765
Creator: U.S. Food and Drug Administration
Published: 1988-10-31

Substantially Equivalent

Biotecx Laboratories, Inc.

FDA 510(k) clearance K883765 for TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE, Substantially Equivalent on 1988-10-31. Applicant: Biotecx Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Biotecx Laboratories, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1988-09-06
Decision date: 1988-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Friendswood, TX, US

Download summary PDF View on FDA.gov ↗

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