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FDA 510(k)

CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)

K-Number: K980528 · 1998-03-03

ApplicantChiron Diagnostics Corp.
Decision Date1998-03-03
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Diagnostics Corp.. It received FDA 510(k) clearance on 1998-03-03 under 510(k) number K980528. 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 CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)?

CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) is a medical device that received FDA 510(k) clearance on 1998-03-03. The listed applicant is Chiron Diagnostics Corp.. The 510(k) number is K980528.

When did CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) receive FDA 510(k) clearance?

CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) received FDA 510(k) clearance on 1998-03-03, under 510(k) number K980528.

Who is the listed applicant for CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)?

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

What is the FDA product code for CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)?

The FDA product code for CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI) is MMI.

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Other records listing Chiron Diagnostics 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.

K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYK991582CHIRON DIAGNOSTICS ACS: 180 FOLATEK991692CHIRON DIAGNOSTICS ACS: 180 FT3K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYK981478ACS:CENTAUR CEAK981839ACS:CENTAUR PSA2 IMMUNOASSAY

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Related Devices (Code: MMI)

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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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