The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Folate On The Access Immunoassay Systems, Model A14208.
| Device ID | K060774 |
| 510k Number | K060774 |
| Device Name: | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Carolyn Anderson |
| Correspondent | Carolyn Anderson BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-22 |
| Decision Date | 2006-04-21 |
| Summary: | summary |