ELECSYS CA 15-3 TEST SYSTEM— 510(k) K001468
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K001468 for ELECSYS CA 15-3 TEST SYSTEM, Substantially Equivalent on 2000-10-23. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- 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
- Indianapolis, IN, US
Recent devices under product code MOI
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