The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Navios Flow Cytometer System.
| Device ID | K130373 |
| 510k Number | K130373 |
| Device Name: | NAVIOS FLOW CYTOMETER SYSTEM |
| Classification | Flow Cytometric Reagents And Accessories. |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147 AVE Miami, FL 33196 -2500 |
| Contact | Nancy Nadler |
| Correspondent | Nancy Nadler BECKMAN COULTER, INC. 11800 SW 147 AVE Miami, FL 33196 -2500 |
| Product Code | OYE |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590205775 | K130373 | 000 |