The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Thyroglobulin Reagents On The Access Immunoassay Systems.
Device ID | K031269 |
510k Number | K031269 |
Device Name: | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
Classification | System, Test, Thyroglobulin |
Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Contact | Lynn Weist |
Correspondent | Lynn Weist BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
Product Code | MSW |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-04-21 |
Decision Date | 2003-05-02 |
Summary: | summary |