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)

CREATINE KINASE REAGENT SYSTEM

K-Number: K952745 · 1995-08-11

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1995-08-11
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K952745. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE REAGENT SYSTEM?

CREATINE KINASE REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K952745.

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

CREATINE KINASE REAGENT SYSTEM received FDA 510(k) clearance on 1995-08-11, under 510(k) number K952745.

Who is the listed applicant for CREATINE KINASE REAGENT SYSTEM?

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

What is the FDA product code for CREATINE KINASE REAGENT SYSTEM?

The FDA product code for CREATINE KINASE REAGENT SYSTEM is CGS.

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 Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

View all 57 devices →

Related Devices (Code: CGS)

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.

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) PtyltdK083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics

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.

↑