The following data is part of a premarket notification filed by Streck with the FDA for Cell-chex With Cppd Crystals.
| Device ID | K110718 |
| 510k Number | K110718 |
| Device Name: | CELL-CHEX WITH CPPD CRYSTALS |
| Classification | Mixture, Control, White-cell And Red-cell Indices |
| Applicant | Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Contact | Deborah Kipp |
| Correspondent | Deborah Kipp Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Product Code | GLQ |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-15 |
| Decision Date | 2011-05-26 |
| Summary: | summary |