The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Gold Standard Diagnostics Borrelia Burgdorferi Vlse-ospc Igg/igm Elisa Test Kit.
Device ID | K203289 |
510k Number | K203289 |
Device Name: | Gold Standard Diagnostics Borrelia Burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit |
Classification | Reagent, Borrelia Serological Reagent |
Applicant | Gold Standard Diagnostics 2851 Spafford St. Davis, CA 95618 |
Contact | Napoleon Monce |
Correspondent | Jennifer Roth Gold Standard Diagnostics 2851 Spafford St. Davis, CA 95618 |
Product Code | LSR |
CFR Regulation Number | 866.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-09 |
Decision Date | 2021-03-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B350GSD0110270 | K203289 | 000 |