ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR— 510(k) K021535
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K021535 for ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR, Substantially Equivalent on 2002-06-27. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code JIT
view allMore clearances from Bayer Diagnostics Corp.
view allRecalls naming K021535
K-number listed on FDA's recall record- Z-2085-2017 — ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
- Z-2086-2017 — ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021535.
Data sourced from openFDA. This site is unofficial and independent of the FDA.