BANDVIEW SYSTEM
FDA 510(k) clearance K012103 · decided 2001-09-14
Clearance details
- K-number
- K012103
- Device name
- BANDVIEW SYSTEM
- Applicant
- Applied Spectral Imaging , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-05
- Decision date
- 2001-09-14
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- LNJ
- Device class
- 2
- Regulation number
- 864.5260
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Ra'Ananna 43373, IL
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| FISHVIEW (K050236) | Applied Spectral Imaging , Ltd. | 2005-06-27 |
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| CYTOSCAN (K864955) | Image Recognition Systems , Ltd. | 1987-03-16 |
| PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST (K861974) | Perceptive Systems, Inc. | 1986-08-04 |
| NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS (K851508) | Nikon, Inc. | 1985-07-12 |
| METACHROME (K851174) | Potomac Medical System | 1985-05-23 |
Recalls involving this device
No recalls on record reference this clearance.