The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Coulter Lin-x Linearity Control.
| Device ID | K081641 |
| 510k Number | K081641 |
| Device Name: | COULTER LIN-X LINEARITY CONTROL |
| 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 | 2008-06-11 |
| Decision Date | 2009-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590233792 | K081641 | 000 |
| 15099590206802 | K081641 | 000 |