CLINITEK MICROALBUMIN REAGENT STRIPS— 510(k) K972706

Name: FDA 510(k) clearance K972706
Creator: U.S. Food and Drug Administration
Published: 1997-09-09

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K972706 for CLINITEK MICROALBUMIN REAGENT STRIPS, Substantially Equivalent on 1997-09-09. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code CJG
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1997-07-21
Decision date: 1997-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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