Thrombomax-Hs with Calcium, Model T6540

FDA 510(k) K010158 · Sigma Diagnostics, Inc.

Substantially Equivalent

510(k) numberK010158

Submission

Device name
Thrombomax-Hs with Calcium, Model T6540
Applicant
Sigma Diagnostics, Inc.
St. Louis, MO, US
Received
January 17, 2001
Decision date
March 22, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GGO – Reagent, Thromboplastin And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7925
Specialty
Hematology

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Questions and answers

When was Thrombomax-Hs with Calcium, Model T6540 cleared by the FDA?

Thrombomax-Hs with Calcium, Model T6540 (K010158) received a 510(k) decision of Substantially Equivalent on March 22, 2001, 64 days after the submission was received.

What is the product code of K010158?

The FDA product code is GGO – Reagent, Thromboplastin And Control, a Class II (moderate risk) device regulated under 21 CFR 864.7925.