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 |