AIA-PACK(R) PROG ASSAY— 510(k) K933269
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K933269 for AIA-PACK(R) PROG ASSAY, Substantially Equivalent on 1993-10-22. Applicant: Tosoh Medics, Inc.. Device class: 1.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code JLS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1620
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
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