The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Gold Standard Diagnostics Anti-nuclear Antibody (ana) Screen Elisa Test Kit.
| Device ID | K131330 |
| 510k Number | K131330 |
| Device Name: | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-08 |
| Decision Date | 2014-01-28 |
| Summary: | summary |