GENESIS
FDA 510(k) clearance K953345 · decided 1995-11-21
Clearance details
- K-number
- K953345
- Device name
- GENESIS
- Applicant
- Tecan U.S., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-12
- Decision date
- 1995-11-21
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- JQW
- Device class
- 1
- Regulation number
- 862.2750
- 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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| IMPACT (K961694) | Matrix Technologies Corp. | 1996-06-21 |
| MEDTEC AUTOBLOT 2000 (K951753) | Medtec, Inc. | 1995-10-17 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001. recall (Z-0996-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Tecan Clinical Workstations with Robonet software recall (Z-1022-04) | Tecan U S Inc | 2004-07-20 |
| Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmwar recall (Z-0869-03) | Tecan U S Inc | 2003-05-29 |