Coag-A-Mate MTX

FDA 510(k) K962857 · Organon Teknika Corp.

Substantially Equivalent

510(k) numberK962857

Submission

Device name
Coag-A-Mate MTX
Applicant
Organon Teknika Corp.
Durham, NC, US
Received
July 22, 1996
Decision date
January 22, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GKP – Instrument, Coagulation, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5400
Specialty
Hematology

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Questions and answers

When was Coag-A-Mate MTX cleared by the FDA?

Coag-A-Mate MTX (K962857) received a 510(k) decision of Substantially Equivalent on January 22, 1997, 184 days after the submission was received.

What is the product code of K962857?

The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.