ST AIA-PACK C-PEPTIDE II CALIBRATOR SET— 510(k) K140648
Substantially EquivalentTosoh Bioscience, Inc.
FDA 510(k) clearance K140648 for ST AIA-PACK C-PEPTIDE II CALIBRATOR SET, Substantially Equivalent on 2014-04-10. Applicant: Tosoh Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Bioscience, Inc.
- 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
- Abbreviated
- Location
- South San Franciso, CA, US
Recent devices under product code JIT
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