The following data is part of a premarket notification filed by Brahms Diagnostica, Llc. with the FDA for Brahms Diagnostica Lumitest Anti-tpo.
| Device ID | K000287 |
| 510k Number | K000287 |
| Device Name: | BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO |
| 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 |