CLINISTAT HEMOGLOBIN REAGENT TEST— 510(k) K885227

Name: FDA 510(k) clearance K885227
Creator: U.S. Food and Drug Administration
Published: 1989-02-24

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K885227 for CLINISTAT HEMOGLOBIN REAGENT TEST, Substantially Equivalent on 1989-02-24. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1988-12-20
Decision date: 1989-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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