The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Coulter Lin-c Linearity Control, Models 7547065, 723503.
| Device ID | K061064 |
| 510k Number | K061064 |
| Device Name: | COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami, FL 33196 -2500 |
| Contact | Nancy Nadler |
| Correspondent | Nancy Nadler 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 | 2006-04-17 |
| Decision Date | 2006-05-17 |
| Summary: | summary |