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FDA 510(k)

TARGET MYOGLOBIN TEST

K-Number: K963680 · 1997-02-06

ApplicantTexas Immunology, Inc.
Decision Date1997-02-06
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TARGET MYOGLOBIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K963680. 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 TARGET MYOGLOBIN TEST?

TARGET MYOGLOBIN TEST is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K963680.

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

TARGET MYOGLOBIN TEST received FDA 510(k) clearance on 1997-02-06, under 510(k) number K963680.

Who is the listed applicant for TARGET MYOGLOBIN TEST?

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

What is the FDA product code for TARGET MYOGLOBIN TEST?

The FDA product code for TARGET MYOGLOBIN TEST is DDR.

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Other records listing Texas Immunology, 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.

K991465DRUG STOPK980153DRUG CHECKK973208FIRST SIGNK972094TARGET CARDIAC TROPONIN I TESTK912246TARGET MICROALBUMINURIA TESTK910073TARGET ASO TEST

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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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