Cleared Traditional

DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA

K935307 · Baxter Diagnostics, Inc. · Hematology

Nov 1994

Decision

385d

Days

Class 2

Risk

About This 510(k) Submission

K935307 is an FDA 510(k) clearance for the DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA, a Antigen, Antiserum, Control, Antithrombin Iii (Class II — Special Controls, product code DDQ), submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 1994, 385 days after receiving the submission on November 2, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number	K935307 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 1993
Decision Date	November 22, 1994
Days to Decision	385 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF