ENZYMUN-TEST PROGESTERONE— 510(k) K910683

Name: FDA 510(k) clearance K910683
Creator: U.S. Food and Drug Administration
Published: 1991-04-08

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K910683 for ENZYMUN-TEST PROGESTERONE, Substantially Equivalent on 1991-04-08. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 1991-02-19
Decision date: 1991-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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