AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT— 510(k) K926563

Name: FDA 510(k) clearance K926563
Creator: U.S. Food and Drug Administration
Published: 1993-03-18

Substantially Equivalent

Bio-Chem Laboratory Systems, Inc.

FDA 510(k) clearance K926563 for AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT, Substantially Equivalent on 1993-03-18. Applicant: Bio-Chem Laboratory Systems, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Chem Laboratory Systems, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1992-12-31
Decision date: 1993-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, NJ, US

Download summary PDF View on FDA.gov ↗

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