The following data is part of a premarket notification filed by Brahms Diagnostica, Llc. with the FDA for Brahms Diagnostica Lumitest Trak Human.
| Device ID | K033454 |
| 510k Number | K033454 |
| Device Name: | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | BRAHMS DIAGNOSTICA, LLC. 35-B SOUTH PEACHTREE ST. Norcross, GA 30071 |
| Contact | William G Frank |
| Correspondent | William G Frank BRAHMS DIAGNOSTICA, LLC. 35-B 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 | 2003-10-30 |
| Decision Date | 2004-03-22 |