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FDA 510(k)

ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY

K-Number: K020217 · 2002-03-15

ApplicantBayer Diagnostics Corp.
Decision Date2002-03-15
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2002-03-15 under 510(k) number K020217. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY?

ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2002-03-15. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K020217.

When did ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY receive FDA 510(k) clearance?

ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY received FDA 510(k) clearance on 2002-03-15, under 510(k) number K020217.

Who is the listed applicant for ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY?

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

What is the FDA product code for ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY?

The FDA product code for ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY is JJX.

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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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