The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for White Iris Leukocyte Differential Analyzer.
| Device ID | K953116 |
| 510k Number | K953116 |
| Device Name: | WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Contact | Harvey L Krasdan |
| Correspondent | Harvey L Krasdan INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1996-05-13 |
| Summary: | summary |