The following data is part of a premarket notification filed by Brahms Diagnostica, Llc. with the FDA for Brahms Diagnostica Dynotest Tg-plus.
| Device ID | K021057 |
| 510k Number | K021057 |
| Device Name: | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS |
| Classification | System, Test, Thyroglobulin |
| 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 | MSW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157631106 | K021057 | 000 |