The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Cd8 Cytospheres Kit.
| Device ID | K923951 |
| 510k Number | K923951 |
| Device Name: | CD8 CYTOSPHERES KIT |
| Classification | Dna-probe, B And T Lymphocyte |
| Applicant | COULTER ELECTRONICS, INC. 600 WEST 20TH ST. Hialeah, FL 33010 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 600 WEST 20TH ST. Hialeah, FL 33010 |
| Product Code | MAM |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-06 |
| Decision Date | 1994-04-25 |