ST AIA-PACK CYSTATIN C, MODEL 025217— 510(k) K093960
Substantially EquivalentTosoh Bioscience, Inc.
FDA 510(k) clearance K093960 for ST AIA-PACK CYSTATIN C, MODEL 025217, Substantially Equivalent on 2010-09-14. Applicant: Tosoh Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Bioscience, Inc.
- Product code
- Code NDY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Franciso, CA, US
Recent devices under product code NDY
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view allRecalls naming K093960
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093960.
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