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FDA 510(k)

TARGET CARDIAC TROPONIN I TEST

K-Number: K972094 · 1997-07-23

ApplicantTexas Immunology, Inc.
Decision Date1997-07-23
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TARGET CARDIAC TROPONIN I TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K972094. 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 TARGET CARDIAC TROPONIN I TEST?

TARGET CARDIAC TROPONIN I TEST is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K972094.

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

TARGET CARDIAC TROPONIN I TEST received FDA 510(k) clearance on 1997-07-23, under 510(k) number K972094.

Who is the listed applicant for TARGET CARDIAC TROPONIN I TEST?

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

What is the FDA product code for TARGET CARDIAC TROPONIN I TEST?

The FDA product code for TARGET CARDIAC TROPONIN I TEST is MMI.

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Other records listing Texas Immunology, 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.

K991465DRUG STOPK980153DRUG CHECKK973208FIRST SIGNK963680TARGET MYOGLOBIN TESTK912246TARGET MICROALBUMINURIA TESTK910073TARGET ASO TEST

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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.

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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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