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FDA 510(k)

IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15

K-Number: K983972 · 1998-12-07

ApplicantDiagnostic Products Corp.
Decision Date1998-12-07
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 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 1998-12-07 under 510(k) number K983972. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15?

IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K983972.

When did IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 receive FDA 510(k) clearance?

IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 received FDA 510(k) clearance on 1998-12-07, under 510(k) number K983972.

Who is the listed applicant for IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15?

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 TROPONIN I, MODEL LKTI1 AND LKT15?

The FDA product code for IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 is MMI.

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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

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Related Devices (Code: MMI)

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.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.

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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