ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY— 510(k) K121981
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K121981 for ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY, Substantially Equivalent on 2013-03-21. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code CEW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1545
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code CEW
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view all- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more
- K162977 — ADVIA 2120i, ADVIA 2120
- K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL
- K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
- K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
Adverse events under product code CEW
product code CEW- Malfunction
- 480
- Total
- 480
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 K121981
K-number listed on FDA's recall record- Z-1512-2013 — ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
- Z-1513-2013 — ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121981.
Data sourced from openFDA. This site is unofficial and independent of the FDA.