TREP-SURE TREPONEMAL ANTIBODY EIA— 510(k) K053570

Name: FDA 510(k) clearance K053570
Creator: U.S. Food and Drug Administration
Published: 2006-08-07

Substantially Equivalent

Phoenix Biotech Corp.

FDA 510(k) clearance K053570 for TREP-SURE TREPONEMAL ANTIBODY EIA, Substantially Equivalent on 2006-08-07. Applicant: Phoenix Biotech Corp.. Device class: 2.

Clearance details

Applicant: Phoenix Biotech Corp.
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2005-12-22
Decision date: 2006-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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