VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428— 510(k) K010550

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K010550 for VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428, Substantially Equivalent on 2001-04-24. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 2001-02-26
Decision date: 2001-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.