FIBRINOGENTEST-O— 510(k) K881685

Substantially Equivalent

Diatech, Inc.

FDA 510(k) clearance K881685 for FIBRINOGENTEST-O, Substantially Equivalent on 1988-08-09. Applicant: Diatech, Inc.. Device class: 2.

Clearance details

Applicant: Diatech, Inc.
Product code: Code GIS
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1988-04-19
Decision date: 1988-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

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