The following data is part of a premarket notification filed by Brahms Diagnostica, Llc. with the FDA for Brahms Diagnostica Lumitest Anti-tg.
Device ID | K000286 |
510k Number | K000286 |
Device Name: | BRAHMS DIAGNOSTICA LUMITEST ANTI-TG |
Classification | System, Test, Thyroid Autoantibody |
Applicant | BRAHMS DIAGNOSTICA, LLC. 29 SOUTH PEACHTREE ST. Norcross, GA 30071 |
Contact | H. Lee Herron |
Correspondent | H. Lee Herron BRAHMS DIAGNOSTICA, LLC. 29 SOUTH PEACHTREE ST. Norcross, GA 30071 |
Product Code | JZO |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-31 |
Decision Date | 2000-03-17 |