THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM— 510(k) K980376

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K980376 for THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM, Substantially Equivalent on 1998-04-23. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 1998-01-30
Decision date: 1998-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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