Heptest-A Quantitative Heparin in Plasma Assay

Q: What is the product code of K853239?

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

FDA 510(k) K853239 · Haemachem, Inc.

Substantially Equivalent

510(k) numberK853239

Submission

Device name: Heptest-A Quantitative Heparin in Plasma Assay
Applicant: Haemachem, Inc.
St. Louis, MO, US
Received: August 1, 1985
Decision date: November 5, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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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K010455	Rotachrom Heparin and Sta -Rotachrom HeparinKFF · Traditional	Diagnostica-Stago	06/07/2001SE
K010193	Hemochron Kaolin-Activated Heparin and Protamine Dosing AssaysKFF · Traditional	International Technidyne Corp.	06/06/2001SE

More from International Technidyne Corp.

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Questions and answers

When was Heptest-A Quantitative Heparin in Plasma Assay cleared by the FDA?

Heptest-A Quantitative Heparin in Plasma Assay (K853239) received a 510(k) decision of Substantially Equivalent on November 5, 1985, 96 days after the submission was received.

What is the product code of K853239?

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