Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VIDAS CREATINE KINASE MB ASSAY 30-421

K-Number: K962549 · 1996-08-30

ApplicantBiomerieux Vitek, Inc.
Decision Date1996-08-30
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIDAS CREATINE KINASE MB ASSAY 30-421 is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1996-08-30 under 510(k) number K962549. 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 VIDAS CREATINE KINASE MB ASSAY 30-421?

VIDAS CREATINE KINASE MB ASSAY 30-421 is a medical device that received FDA 510(k) clearance on 1996-08-30. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K962549.

When did VIDAS CREATINE KINASE MB ASSAY 30-421 receive FDA 510(k) clearance?

VIDAS CREATINE KINASE MB ASSAY 30-421 received FDA 510(k) clearance on 1996-08-30, under 510(k) number K962549.

Who is the listed applicant for VIDAS CREATINE KINASE MB ASSAY 30-421?

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

What is the FDA product code for VIDAS CREATINE KINASE MB ASSAY 30-421?

The FDA product code for VIDAS CREATINE KINASE MB ASSAY 30-421 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biomerieux Vitek, Inc. as applicant

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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

View all 49 devices →

Related Devices (Code: JHX)

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.

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical DiagnosticsK163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical ApsK120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical ApsK081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku IatronK051650STRATUS 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.

↑