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)

ELECSYS MYOGLOBIN STAT ASSAY

K-Number: K983176 · 1998-09-24

ApplicantBoehringer Mannheim Corp.
Decision Date1998-09-24
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELECSYS MYOGLOBIN STAT ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1998-09-24 under 510(k) number K983176. 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 ELECSYS MYOGLOBIN STAT ASSAY?

ELECSYS MYOGLOBIN STAT ASSAY is a medical device that received FDA 510(k) clearance on 1998-09-24. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K983176.

When did ELECSYS MYOGLOBIN STAT ASSAY receive FDA 510(k) clearance?

ELECSYS MYOGLOBIN STAT ASSAY received FDA 510(k) clearance on 1998-09-24, under 510(k) number K983176.

Who is the listed applicant for ELECSYS MYOGLOBIN STAT ASSAY?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS MYOGLOBIN STAT ASSAY?

The FDA product code for ELECSYS MYOGLOBIN STAT ASSAY 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 Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

View all 340 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.

↑