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FDA 510(k)

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

K-Number: K083260 · 2009-10-16

ApplicantRoche Diagnostics
Decision Date2009-10-16
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2009-10-16 under 510(k) number K083260. 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, AND ELECSYS MYOGLOBIN?

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN is a medical device that received FDA 510(k) clearance on 2009-10-16. The listed applicant is Roche Diagnostics. The 510(k) number is K083260.

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

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN received FDA 510(k) clearance on 2009-10-16, under 510(k) number K083260.

Who is the listed applicant for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN?

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

What is the FDA product code for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN?

The FDA product code for ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN is DDR.

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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.K080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics Corp.K042924ARCHITECT STAT MYO IMMUNOASSAYFisher 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.

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