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FDA 510(k)

OPUS MYOGLOBIN TEST SYSTEM

K-Number: K915850 · 1992-03-17

ApplicantPb Diagnostic Systems, Inc.
Decision Date1992-03-17
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OPUS MYOGLOBIN TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1992-03-17 under 510(k) number K915850. 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 OPUS MYOGLOBIN TEST SYSTEM?

OPUS MYOGLOBIN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-17. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K915850.

When did OPUS MYOGLOBIN TEST SYSTEM receive FDA 510(k) clearance?

OPUS MYOGLOBIN TEST SYSTEM received FDA 510(k) clearance on 1992-03-17, under 510(k) number K915850.

Who is the listed applicant for OPUS MYOGLOBIN TEST SYSTEM?

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

What is the FDA product code for OPUS MYOGLOBIN TEST SYSTEM?

The FDA product code for OPUS MYOGLOBIN TEST SYSTEM is DDR.

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Other records listing Pb Diagnostic Systems, Inc. as applicant

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K940507OPUS FT4 TEST SYSTEMK934762OPUS PROCAINAMIDE TEST SYSTEMK933389OPUS CMV-GK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPA

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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.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.

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