DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA— 510(k) K935307

Name: FDA 510(k) clearance K935307
Creator: U.S. Food and Drug Administration
Published: 1994-11-22

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K935307 for DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA, Substantially Equivalent on 1994-11-22. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code DDQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1993-11-02
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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