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 |