The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Coulter Lin-x Linearity Control, Model A81196.
| Device ID | K100790 |
| 510k Number | K100790 |
| Device Name: | COULTER LIN-X LINEARITY CONTROL, MODEL A81196 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Contact | Lourdes M Coba |
| Correspondent | Lourdes M Coba BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2010-12-21 |
| Summary: | summary |