ENZYMUN-TEST PSA— 510(k) K965085

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K965085 for ENZYMUN-TEST PSA, Substantially Equivalent on 1997-03-19. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 1996-12-19
Decision date: 1997-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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