BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST— 510(k) K925183

Name: FDA 510(k) clearance K925183
Creator: U.S. Food and Drug Administration
Published: 1993-02-23

Substantially Equivalent

Princeton Biomedix

FDA 510(k) clearance K925183 for BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST, Substantially Equivalent on 1993-02-23. Applicant: Princeton Biomedix. Device class: 2.

Clearance details

Applicant: Princeton Biomedix
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1992-10-14
Decision date: 1993-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

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