COULTER GEN-S SYSTEM
FDA 510(k) clearance K962988 · decided 1996-10-30
Clearance details
- K-number
- K962988
- Device name
- COULTER GEN-S SYSTEM
- Applicant
- Coulter Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-01
- Decision date
- 1996-10-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GKL
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer recall (Z-1956-2011) | Beckman Coulter Inc. | 2011-04-12 |
| COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyze recall (Z-0315-2008) | Beckman Coulter Inc | 2007-12-22 |
| COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6 recall (Z-0475-06) | Beckman Coulter Inc | 2006-02-04 |
| Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell recall (Z-0571-03) | Beckman Coulter Inc | 2003-02-25 |