The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Borrelia Burgdorferi Igm Blot Test.
| Device ID | K113846 |
| 510k Number | K113846 |
| Device Name: | BORRELIA BURGDORFERI IGM BLOT TEST |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis, CA 95618 |
| Contact | Napoleon Monce |
| Correspondent | Napoleon Monce GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD 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 | 2011-12-29 |
| Decision Date | 2012-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B350GSD1010230 | K113846 | 000 |
| B350GSD0410230 | K113846 | 000 |
| B350GSD0110190 | K113846 | 000 |
| B350GSD0110230 | K113846 | 000 |