
Bayer Diagnostics Corp.
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ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY is an FDA 510(k)-cleared medical device (K020217) manufactured by Bayer Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 14, 2002. Regulation: 8.