AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM— 510(k) K911625

Name: FDA 510(k) clearance K911625
Creator: U.S. Food and Drug Administration
Published: 1991-09-05

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K911625 for AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM, Substantially Equivalent on 1991-09-05. 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: 1991-04-11
Decision date: 1991-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mishawaka, IN, US

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