The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Volumet Cd4 + And Cd8 + T Lymphocyte Count Test Kit.
| Device ID | K940003 |
| 510k Number | K940003 |
| Device Name: | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT |
| Classification | Counter, Differential Cell |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | Laurie A Ridener |
| Correspondent | Laurie A Ridener BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-03 |
| Decision Date | 1995-10-19 |