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FDA 510(k)

ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS

K-Number: K080167 · 2008-08-08

ApplicantSiemens Healthcare Diagnostics
Decision Date2008-08-08
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K080167. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS?

ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K080167.

When did ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS receive FDA 510(k) clearance?

ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS received FDA 510(k) clearance on 2008-08-08, under 510(k) number K080167.

Who is the listed applicant for ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS?

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

What is the FDA product code for ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS?

The FDA product code for ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS is CEC.

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Related Devices (Code: CEC)

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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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