AIA-PACK CEA CALIBRATION VERIFICATION TEST SET— 510(k) K924857
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K924857 for AIA-PACK CEA CALIBRATION VERIFICATION TEST SET, Substantially Equivalent on 1993-03-18. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code DHX
- 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 DHX
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