QUALITROL ANA CONTROL SERUM SET— 510(k) K961815

Name: FDA 510(k) clearance K961815
Creator: U.S. Food and Drug Administration
Published: 1996-09-27

Substantially Equivalent

Consolidated Technologies, Inc.

FDA 510(k) clearance K961815 for QUALITROL ANA CONTROL SERUM SET, Substantially Equivalent on 1996-09-27. Applicant: Consolidated Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Consolidated Technologies, Inc.
Product code: Code LKJ
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1996-05-10
Decision date: 1996-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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