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FDA 510(k)

STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K965213 · 1997-02-10

ApplicantDade Intl., Inc.
Decision Date1997-02-10
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K965213. 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 MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY?

STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Dade Intl., Inc.. The 510(k) number is K965213.

When did STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1997-02-10, under 510(k) number K965213.

Who is the listed applicant for STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY is DDR.

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Other records listing Dade Intl., 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.

K974343DADE INNOVINK970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROLK973668CARDIAC TROPONIN-I (TROP) CALIBRATORK972524DRIED GRAM-POSITIVE MIC/COMBO PANELSK972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

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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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