PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
FDA 510(k) clearance K861974 · decided 1986-08-04
Clearance details
- K-number
- K861974
- Device name
- PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
- Applicant
- Perceptive Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-21
- Decision date
- 1986-08-04
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- LNJ
- Device class
- 2
- Regulation number
- 864.5260
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FISHVIEW (K050236) | Applied Spectral Imaging , Ltd. | 2005-06-27 |
| BANDVIEW SYSTEM (K012103) | Applied Spectral Imaging , Ltd. | 2001-09-14 |
| IKAROS (K940240) | Metasystems GmbH | 1995-02-24 |
| ACLAIMS-IS (K912085) | W-Technology | 1991-10-31 |
| GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (K902311) | Applied Imaging Corp. | 1990-08-20 |
| AKS II (K895095) | Amoco Technology Co. | 1990-02-09 |
| KARYOTEC 100 (K872755) | Amcor Electronics, Ltd. | 1987-09-01 |
| CYTOSCAN (K864955) | Image Recognition Systems , Ltd. | 1987-03-16 |
| 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.