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FDA 510(k)

MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

K-Number: K962344 · 1996-08-15

ApplicantBayer Corp.
Decision Date1996-08-15
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K962344. 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 MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)?

MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Bayer Corp.. The 510(k) number is K962344.

When did MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) receive FDA 510(k) clearance?

MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) received FDA 510(k) clearance on 1996-08-15, under 510(k) number K962344.

Who is the listed applicant for MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)?

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

What is the FDA product code for MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)?

The FDA product code for MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) is DDR.

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Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

View all 96 devices →

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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