ACCESS CHLAMYDIA ASSAY— 510(k) K960850

Name: FDA 510(k) clearance K960850
Creator: U.S. Food and Drug Administration
Published: 1997-02-04

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K960850 for ACCESS CHLAMYDIA ASSAY, Substantially Equivalent on 1997-02-04. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1996-03-01
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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