N-ASSAY TIA ANTITHROMBIN III TEST KIT— 510(k) K972257

Name: FDA 510(k) clearance K972257
Creator: U.S. Food and Drug Administration
Published: 1997-10-20

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K972257 for N-ASSAY TIA ANTITHROMBIN III TEST KIT, Substantially Equivalent on 1997-10-20. Applicant: Crestat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code DDQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1997-06-17
Decision date: 1997-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, CT, US

Download summary PDF View on FDA.gov ↗

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