Coacute Heparin

FDA 510(k) K952514 · Chromogenix AB

Substantially Equivalent

510(k) numberK952514

Submission

Device name
Coacute Heparin
Applicant
Chromogenix AB
Franklin, OH, US
Received
May 31, 1995
Decision date
November 20, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KFF – Assay, Heparin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7525
Specialty
Hematology

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More from International Technidyne Corp.

510(k)DeviceDecision
K963111Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SGGW · Traditional 12/23/1996SE
K952515Coacute Antithrombin R Chromogenic AssayJBQ · Traditional 01/23/1996SE
K922201Coamate Protein C Chromogenic AssayGGP · Traditional 12/07/1992SE

Questions and answers

When was Coacute Heparin cleared by the FDA?

Coacute Heparin (K952514) received a 510(k) decision of Substantially Equivalent on November 20, 1995, 173 days after the submission was received.

What is the product code of K952514?

The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.