HEMASTIX REAGENT STRIPS— 510(k) K905396

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K905396 for HEMASTIX REAGENT STRIPS, Substantially Equivalent on 1991-02-11. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code JIO
Advisory panel: Hematology
Date received: 1990-11-30
Decision date: 1991-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mishawaka, IN, US

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