ENZYMUN TEST(R) INSULIN— 510(k) K901135

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K901135 for ENZYMUN TEST(R) INSULIN, Substantially Equivalent on 1990-04-03. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CFP
Advisory panel: Clinical Chemistry
Date received: 1990-03-12
Decision date: 1990-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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