GENESIS RMP
FDA 510(k) clearance K963268 · decided 1997-03-18
Clearance details
- K-number
- K963268
- Device name
- GENESIS RMP
- Applicant
- Tecan U.S., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-20
- Decision date
- 1997-03-18
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- JRA
- Device class
- 1
- Regulation number
- 862.2680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Research Triangle Park, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.