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FDA 510(k)

ACS:CENTAUR AFP

K-Number: K981592 · 1998-07-07

ApplicantChiron Diagnostics Corp.
Decision Date1998-07-07
Product CodeLOQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACS:CENTAUR AFP 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 1998-07-07 under 510(k) number K981592. The device is classified under product code LOQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS:CENTAUR AFP?

ACS:CENTAUR AFP is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Chiron Diagnostics Corp.. The 510(k) number is K981592.

When did ACS:CENTAUR AFP receive FDA 510(k) clearance?

ACS:CENTAUR AFP received FDA 510(k) clearance on 1998-07-07, under 510(k) number K981592.

Who is the listed applicant for ACS:CENTAUR AFP?

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 ACS:CENTAUR AFP?

The FDA product code for ACS:CENTAUR AFP is LOQ.

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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