FDA 510(k)

CREATINE KINASE REAGENT

K-Number: K980012 · 1998-02-25

Decision Date1998-02-25

Product CodeJHX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Ac Biochemicals, Inc.. It received FDA 510(k) clearance on 1998-02-25 under 510(k) number K980012. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE REAGENT?

CREATINE KINASE REAGENT is a medical device that received FDA 510(k) clearance on 1998-02-25. The listed applicant is Ac Biochemicals, Inc.. The 510(k) number is K980012.

When did CREATINE KINASE REAGENT receive FDA 510(k) clearance?

CREATINE KINASE REAGENT received FDA 510(k) clearance on 1998-02-25, under 510(k) number K980012.

Who is the listed applicant for CREATINE KINASE REAGENT?

The FDA 510(k) record lists Ac Biochemicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATINE KINASE REAGENT?

The FDA product code for CREATINE KINASE REAGENT is JHX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ac Biochemicals, Inc. as applicant

K982539HDLC PRECIPITATING REAGENT K980013AMYLASE

Related Devices (Code: JHX)

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps K120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical Aps K081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku Iatron K051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.