COAGULATION CONTROL PLASMA LEVEL 1/2/3— 510(k) K841461

Name: FDA 510(k) clearance K841461
Creator: U.S. Food and Drug Administration
Published: 1984-05-02

Substantially Equivalent

Diatech, Inc.

FDA 510(k) clearance K841461 for COAGULATION CONTROL PLASMA LEVEL 1/2/3, Substantially Equivalent on 1984-05-02. Applicant: Diatech, Inc.. Device class: 2.

Clearance details

Applicant: Diatech, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1984-04-09
Decision date: 1984-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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