The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cell-chex Rbc.
| Device ID | K811741 |
| 510k Number | K811741 |
| Device Name: | CELL-CHEX RBC |
| Classification | Calibrator For Cell Indices |
| Applicant | STRECK LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRX |
| CFR Regulation Number | 864.8150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-19 |
| Decision Date | 1981-09-24 |