GENESIS RMP— 510(k) K963268
Substantially EquivalentTecan U.S., Inc.
FDA 510(k) clearance K963268 for GENESIS RMP, Substantially Equivalent on 1997-03-18. Applicant: Tecan U.S., Inc.. Device class: 1.
Clearance details
- Applicant
- Tecan U.S., Inc.
- Product code
- Code JRA
- Device class
- Class 1
- Regulation
- 21 CFR 862.2680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Research Triangle Park, NC, US
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