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)

MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST

K-Number: K982679 · 1998-10-07

ApplicantSpectral Diagnostics, Inc.
Decision Date1998-10-07
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-10-07 under 510(k) number K982679. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST?

MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST is a medical device that received FDA 510(k) clearance on 1998-10-07. The listed applicant is Spectral Diagnostics, Inc.. The 510(k) number is K982679.

When did MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST receive FDA 510(k) clearance?

MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST received FDA 510(k) clearance on 1998-10-07, under 510(k) number K982679.

Who is the listed applicant for MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST?

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

What is the FDA product code for MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST?

The FDA product code for MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST is DDR.

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 Spectral Diagnostics, 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.

K052519SPECTRAL WEST NILE VIRUS IGM STATUS TESTK030057SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TESTK022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTK020950SPECTRAL'S 2 IN 1 (TNI-MYO)K014105SPECTRAL'S TROPONIN IK992127CARDIOQUANT TROPONIN I TEST

View all 11 devices →

Related Devices (Code: DDR)

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.

K231832Access MyoglobinBeckman Coulter, Inc.K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme LaboratoriesK122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche DiagnosticsK080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics Corp.

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.

↑