FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN— 510(k) K812298

Name: FDA 510(k) clearance K812298
Creator: U.S. Food and Drug Administration
Published: 1981-12-17

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K812298 for FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN, Substantially Equivalent on 1981-12-17. Applicant: Syn-Kit, Inc.. Device class: 2.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1981-08-14
Decision date: 1981-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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