Cleared Traditional

THROMBOMAX-HS WITH CALCIUM, MODEL T6540

K010158 · Sigma Diagnostics, Inc. · Hematology

Mar 2001

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K010158 is an FDA 510(k) clearance for the THROMBOMAX-HS WITH CALCIUM, MODEL T6540, a Reagent, Thromboplastin And Control (Class II — Special Controls, product code GGO), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 22, 2001, 64 days after receiving the submission on January 17, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number	K010158 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2001
Decision Date	March 22, 2001
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF