The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Thyroglobulin Reagents On The Access Analyzer.
| Device ID | K002905 |
| 510k Number | K002905 |
| Device Name: | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER |
| Classification | System, Test, Thyroglobulin |
| Applicant | BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 San Diego, CA 92196 |
| Contact | Mara Caler |
| Correspondent | Mara Caler BECKMAN COULTER, INC. 7330 CARROLL RD. P.O. BOX 269006 San Diego, CA 92196 |
| Product Code | MSW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-18 |
| Decision Date | 2000-10-19 |