BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST— 510(k) K925355

Name: FDA 510(k) clearance K925355
Creator: U.S. Food and Drug Administration
Published: 1994-07-12

Substantially Equivalent

Princeton Biomedix

FDA 510(k) clearance K925355 for BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST, Substantially Equivalent on 1994-07-12. Applicant: Princeton Biomedix. Device class: 2.

Clearance details

Applicant: Princeton Biomedix
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1992-10-22
Decision date: 1994-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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