ANTITHROMBIN III CHROMOGENIC ASSAY— 510(k) K936196

Name: FDA 510(k) clearance K936196
Creator: U.S. Food and Drug Administration
Published: 1994-05-04

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K936196 for ANTITHROMBIN III CHROMOGENIC ASSAY, Substantially Equivalent on 1994-05-04. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1993-12-29
Decision date: 1994-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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