AIA-PACK BRCA, ST AIA PACK BRCA— 510(k) K010796
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K010796 for AIA-PACK BRCA, ST AIA PACK BRCA, Substantially Equivalent on 2001-08-16. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code MOI
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Recent devices under product code MOI
view allMore clearances from Tosoh Medics, Inc.
view allRecalls naming K010796
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 K010796.
Data sourced from openFDA. This site is unofficial and independent of the FDA.