N-ASSAY TIA FIBRINOGEN TEST KIT— 510(k) K965113

Name: FDA 510(k) clearance K965113
Creator: U.S. Food and Drug Administration
Published: 1997-04-16

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K965113 for N-ASSAY TIA FIBRINOGEN TEST KIT, Substantially Equivalent on 1997-04-16. Applicant: Crestat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1996-12-20
Decision date: 1997-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, CT, US

Download summary PDF View on FDA.gov ↗

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