The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cd-chex Cd4 Low.
| Device ID | K931825 |
| 510k Number | K931825 |
| Device Name: | CD-CHEX CD4 LOW |
| Classification | Control, White-cell |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Hal Sornson |
| Correspondent | Hal Sornson STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Product Code | GGL |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-06 |
| Decision Date | 1994-06-06 |