ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY— 510(k) K020217
Substantially EquivalentBayer 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.. Device class: 1.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code JJX
view allMore clearances from Bayer Diagnostics Corp.
view allAdverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K020217
K-number listed on FDA's recall record- Z-0173-2014 — ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
- Z-1514-2013 — ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
- Z-1515-2013 — ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020217.
Data sourced from openFDA. This site is unofficial and independent of the FDA.