ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY— 510(k) K020217

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K020217 for ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY, Substantially Equivalent on 2002-03-15. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2002-01-22
Decision date: 2002-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.