Lifesign, Care Point, Vitalsign, Accusign

Q: What is the product code of K944325?

The FDA product code is JHW – U.V. Method, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.

FDA 510(k) K944325 · Princeton BioMeditech Corp.

Substantially Equivalent

510(k) numberK944325

Submission

Device name: Lifesign, Care Point, Vitalsign, Accusign
Applicant: Princeton BioMeditech Corp.
Monmouth Junction, NJ, US
Received: September 2, 1994
Decision date: February 22, 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: JHW – U.V. Method, Cpk Isoenzymes
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1215
Specialty: Clinical Chemistry

Other 510(k)s with product code JHW

510(k)	Device	Applicant	Decision
K162526	Creatine Kinase-MBJHW · Traditional	Roche Diagnostics	05/26/2017SE
K141265	Elitech Clinical Systems Envoy 500 CK Reagent KitJHW · Traditional	Elitechgroup	07/18/2014SE
K122083	Elitech Clinical Systems CK Nac SLJHW · Traditional	Elitechgroup	08/22/2012SE
K023744	Wiener Lab. Ck-Mb DS UV Unitest, Model 28 X 2.5 ML Cat. Nr. 1271354JHW · Traditional	Wiener Laboratories Saic	01/03/2003SE
K003158	Roche Diagnostics Ck-MbJHW · Traditional	Roche Diagnostics Corp.	12/18/2000SE
K961501	Elecsys Ck-MbJHW · Traditional	Boehringer Mannheim Corp.	06/11/1996SE
K950186	Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJHW · Traditional	Miles, Inc.	03/13/1995SE
K942958	Creatine Kinase MB Determination (UV)JHW · Traditional	Biochemical Trade, Inc.	11/21/1994SE
K935924	Axsym Ck-MbJHW · Traditional	Abbott Laboratories	06/21/1994SE
K931050	Cardio Rep CK Isoenzyme Kit - 3310JHW · Traditional	Helena Laboratories	04/20/1993SE

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Questions and answers

When was Lifesign, Care Point, Vitalsign, Accusign cleared by the FDA?

Lifesign, Care Point, Vitalsign, Accusign (K944325) received a 510(k) decision of Substantially Equivalent on February 22, 1995, 173 days after the submission was received.

What is the product code of K944325?

The FDA product code is JHW – U.V. Method, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.