AMES DCA 2000 HEMOGLOBIN ALC CONTROLS— 510(k) K940971

Name: FDA 510(k) clearance K940971
Creator: U.S. Food and Drug Administration
Published: 1994-07-19

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K940971 for AMES DCA 2000 HEMOGLOBIN ALC CONTROLS, Substantially Equivalent on 1994-07-19. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1994-03-02
Decision date: 1994-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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