Creatine Kinase Reagent

Q: What is the product code of K980012?

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

FDA 510(k) K980012 · Ac Biochemicals, Inc.

Substantially Equivalent

510(k) numberK980012

Submission

Device name: Creatine Kinase Reagent
Applicant: Ac Biochemicals, Inc.
Irvine, CA, US
Received: January 2, 1998
Decision date: February 25, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: JHX – Fluorometric Method, Cpk Or Isoenzymes
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1215
Specialty: Clinical Chemistry

Other 510(k)s with product code JHX

510(k)	Device	Applicant	Decision
K234005	Access CK-MBJHX · Traditional	Beckman Coulter, Inc.	02/16/2024SE
K212648	VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional	Ortho Clinical Diagnostics	01/28/2022SE
K163462	AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX · Traditional	Radiometer Medical Aps	09/21/2017SE
K120326	AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…JHX · Traditional	Radiometer Medical Aps	11/21/2012SE
K081360	Pathfast Ck-Mb-Ii, Pathfast Myo-IiJHX · Traditional	Mitsubishi Kagaku Iatron	08/17/2009SE
K051650	Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…JHX · Traditional	Dade Behring, Inc.	09/08/2005SE
K041596	Architect Stat Ck-Mb ImmunoassayJHX · Traditional	Fisher Diagnostics	07/21/2004SE
K033747	Ramp Ck-Mb AssayJHX · Traditional	Response Biomedical Corp.	05/17/2004SE
K034055	Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special	Diagnostic Products Corp.	01/21/2004SE
K030012	Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372JHX · Special	Beckman Coulter, Inc.	01/17/2003SE

More from Beckman Coulter, Inc.

510(k)	Device	Decision
K982539	HDLC Precipitating ReagentLBS · Traditional	09/15/1998SE
K980013	AmylaseCIJ · Traditional	02/04/1998SE

Questions and answers

When was Creatine Kinase Reagent cleared by the FDA?

Creatine Kinase Reagent (K980012) received a 510(k) decision of Substantially Equivalent on February 25, 1998, 54 days after the submission was received.

What is the product code of K980012?

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