The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Coulter Lh 750 Hematology Analyzer, Model 6605632.
| Device ID | K011342 |
| 510k Number | K011342 |
| Device Name: | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 |
| Classification | Counter, Differential Cell |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Contact | Stan Sugrue |
| Correspondent | Stan Sugrue BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2001-07-09 |