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FDA 510(k)

IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5

K-Number: K983970 · 1998-11-25

ApplicantDiagnostic Products Corp.
Decision Date1998-11-25
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K983970. 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 IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5?

IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K983970.

When did IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 receive FDA 510(k) clearance?

IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983970.

Who is the listed applicant for IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5?

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

What is the FDA product code for IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5?

The FDA product code for IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 is DDR.

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Other records listing Diagnostic Products 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 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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