CROATEST (R) RHEUMATOID DIAGNOSTIC— 510(k) K904416

Name: FDA 510(k) clearance K904416
Creator: U.S. Food and Drug Administration
Published: 1991-06-24

Substantially Equivalent

Biotrax, Inc.

FDA 510(k) clearance K904416 for CROATEST (R) RHEUMATOID DIAGNOSTIC, Substantially Equivalent on 1991-06-24. Applicant: Biotrax, Inc.. Device class: 1.

Clearance details

Applicant: Biotrax, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1990-09-27
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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