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

Name: FDA 510(k) clearance K010550
Creator: U.S. Food and Drug Administration
Published: 2001-04-24

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.. Device class: 2.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code LTJ
Device class: Class 2
Regulation: 21 CFR 866.6010
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 ↗

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