ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR— 510(k) K021532
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K021532 for ADVIA CENTAUR AND ACS:180 C-PEPTIDE 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
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