RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO— 510(k) K844767

Name: FDA 510(k) clearance K844767
Creator: U.S. Food and Drug Administration
Published: 1985-02-01

Substantially Equivalent

Biotecx Laboratories, Inc.

FDA 510(k) clearance K844767 for RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO, Substantially Equivalent on 1985-02-01. Applicant: Biotecx Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Biotecx Laboratories, Inc.
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1984-12-07
Decision date: 1985-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Friendswood, TX, US

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