ADVIA CENTAUR HOMOCYSTEINE ASSAY— 510(k) K013406
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K013406 for ADVIA CENTAUR HOMOCYSTEINE ASSAY, Substantially Equivalent on 2001-12-18. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code LPS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1377
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code LPS
view all- K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
- K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT
- K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K113793 — HOMOCYSTEINE TEST
- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
More clearances from Bayer Diagnostics Corp.
view allRecalls naming K013406
K-number listed on FDA's recall record- Z-1822-2025 — ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
- Z-1960-2014 — ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013406.
Data sourced from openFDA. This site is unofficial and independent of the FDA.