ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS— 510(k) K012777
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K012777 for ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS, Substantially Equivalent on 2001-10-22. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code JZO
view allMore clearances from Bayer Corp.
view all- K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER
- K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY
- K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Recalls naming K012777
K-number listed on FDA's recall record- Z-1233-2019 — Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
- Z-1234-2019 — SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
- Z-1235-2019 — Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
- Z-1236-2019 — Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012777.
Data sourced from openFDA. This site is unofficial and independent of the FDA.