510(k) K895095
- Device
- AKS II
- Applicant
- AMOCO TECHNOLOGY CO.
- 510(k) number
- K895095
- Product code
- LNJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-09
- Date received
- 1989-08-14
- Regulation
- 864.5260
- Classification name
- Analyzer, Chromosome, Automated
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARIANNE URBAUER
- Address
- Amoco Research Center P.O. Box 400 Naperville IL US 60566 60566
FDA Registration Numbers#
- 9615060
- 9680625
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LNJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050236 | FISHVIEW | Applied Spectral Imaging , Ltd. | 2005-06-27 |
| K012103 | BANDVIEW SYSTEM | Applied Spectral Imaging , Ltd. | 2001-09-14 |
| K940240 | IKAROS | Metasystems GmbH | 1995-02-24 |
| K912085 | ACLAIMS-IS | W-Technology | 1991-10-31 |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | Applied Imaging Corp. | 1990-08-20 |
| K872755 | KARYOTEC 100 | Amcor Electronics, Ltd. | 1987-09-01 |
| K864955 | CYTOSCAN | Image Recognition Systems , Ltd. | 1987-03-16 |
| K861974 | PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST | Perceptive Systems, Inc. | 1986-08-04 |
| K851508 | NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS | Nikon, Inc. | 1985-07-12 |
| K851174 | METACHROME | Potomac Medical System | 1985-05-23 |
Legacy Summary#
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FDA Review#
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