CIBA CORNING ACS PROLACTIN IMMUNOASSAY— 510(k) K904714
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K904714 for CIBA CORNING ACS PROLACTIN IMMUNOASSAY, Substantially Equivalent on 1990-11-07. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code CFT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1625
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Walpole, MA, US
Recent devices under product code CFT
view allMore clearances from Ciba Corning Diagnostics Corp.
view allRecalls naming K904714
K-number listed on FDA's recall record- Z-2409-2012 — ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur¿ Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
- Z-2410-2012 — ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904714.
Data sourced from openFDA. This site is unofficial and independent of the FDA.