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FDA 510(k)

STRATUS CS MYOGLOBIN (MYO) TESTPAK

K-Number: K981102 · 1998-04-27

ApplicantDade Behring, Inc.
Decision Date1998-04-27
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

STRATUS CS MYOGLOBIN (MYO) TESTPAK is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 1998-04-27 under 510(k) number K981102. 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 STRATUS CS MYOGLOBIN (MYO) TESTPAK?

STRATUS CS MYOGLOBIN (MYO) TESTPAK is a medical device that received FDA 510(k) clearance on 1998-04-27. The listed applicant is Dade Behring, Inc.. The 510(k) number is K981102.

When did STRATUS CS MYOGLOBIN (MYO) TESTPAK receive FDA 510(k) clearance?

STRATUS CS MYOGLOBIN (MYO) TESTPAK received FDA 510(k) clearance on 1998-04-27, under 510(k) number K981102.

Who is the listed applicant for STRATUS CS MYOGLOBIN (MYO) TESTPAK?

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

What is the FDA product code for STRATUS CS MYOGLOBIN (MYO) TESTPAK?

The FDA product code for STRATUS CS MYOGLOBIN (MYO) TESTPAK 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.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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