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FDA 510(k)

TROPONIN-I TEST SYSTEM

K-Number: K964862 · 1997-02-10

ApplicantDade Intl., Inc.
Decision Date1997-02-10
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TROPONIN-I TEST SYSTEM 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 K964862. 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 TROPONIN-I TEST SYSTEM?

TROPONIN-I TEST SYSTEM 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 K964862.

When did TROPONIN-I TEST SYSTEM receive FDA 510(k) clearance?

TROPONIN-I TEST SYSTEM received FDA 510(k) clearance on 1997-02-10, under 510(k) number K964862.

Who is the listed applicant for TROPONIN-I TEST SYSTEM?

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 TROPONIN-I TEST SYSTEM?

The FDA product code for TROPONIN-I TEST SYSTEM is MMI.

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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: 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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