AIA-PACK RBC FOLATE— 510(k) K091332
Substantially EquivalentTosoh Bioscience, Inc.
FDA 510(k) clearance K091332 for AIA-PACK RBC FOLATE, Substantially Equivalent on 2009-10-02. Applicant: Tosoh Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Bioscience, Inc.
- Product code
- Code CGN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1295
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grove City, OH, US
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