The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Cd4 Cytospheres Kit.
| Device ID | K921279 |
| 510k Number | K921279 |
| Device Name: | CD4 CYTOSPHERES KIT |
| Classification | Counter, Differential Cell |
| Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1992-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590540807 | K921279 | 000 |