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FDA 510(k)

CARDIOQUANT TROPONIN I TEST

K-Number: K992127 · 1999-10-04

ApplicantSpectral Diagnostics, Inc.
Decision Date1999-10-04
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIOQUANT TROPONIN I TEST is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-10-04 under 510(k) number K992127. 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 CARDIOQUANT TROPONIN I TEST?

CARDIOQUANT TROPONIN I TEST is a medical device that received FDA 510(k) clearance on 1999-10-04. The listed applicant is Spectral Diagnostics, Inc.. The 510(k) number is K992127.

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

CARDIOQUANT TROPONIN I TEST received FDA 510(k) clearance on 1999-10-04, under 510(k) number K992127.

Who is the listed applicant for CARDIOQUANT TROPONIN I TEST?

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

What is the FDA product code for CARDIOQUANT TROPONIN I TEST?

The FDA product code for CARDIOQUANT TROPONIN I TEST is MMI.

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Other records listing Spectral Diagnostics, 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.

K052519SPECTRAL WEST NILE VIRUS IGM STATUS TESTK030057SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TESTK022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTK020950SPECTRAL'S 2 IN 1 (TNI-MYO)K014105SPECTRAL'S TROPONIN IK991447CARDIOQUANT CARDIAC ASSESSMENT CONTROLS

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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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