The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Folate Assay (modification).
| Device ID | K955434 |
| 510k Number | K955434 |
| Device Name: | ACCESS FOLATE ASSAY (MODIFICATION) |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Kimnis Walker |
| Correspondent | Kimnis Walker BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1996-01-29 |