BAYER PSA ASSAY— 510(k) K994221

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K994221 for BAYER PSA ASSAY, Substantially Equivalent on 2000-04-13. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 1999-12-15
Decision date: 2000-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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