The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Gold Standard Diagnostics Borrelia Burgdorferi Igm Elisa Test Kit.
| Device ID | K200023 |
| 510k Number | K200023 |
| Device Name: | Gold Standard Diagnostics Borrelia Burgdorferi IgM ELISA Test Kit |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | Gold Standard Diagnostics 2851 Spafford St. Davis, CA 95618 |
| Contact | Napoleon Monce |
| Correspondent | Napoleon Monce 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 | 2020-01-06 |
| Decision Date | 2020-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B350GSD0110260 | K200023 | 000 |