QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET— 510(k) K961912

Name: FDA 510(k) clearance K961912
Creator: U.S. Food and Drug Administration
Published: 1996-08-15

Substantially Equivalent

Consolidated Technologies, Inc.

FDA 510(k) clearance K961912 for QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET, Substantially Equivalent on 1996-08-15. Applicant: Consolidated Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Consolidated Technologies, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1996-05-17
Decision date: 1996-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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