The following data is part of a premarket notification filed by Diagnostics Direct, Llc. with the FDA for Syphilis Health Check.
| Device ID | K102400 |
| 510k Number | K102400 |
| Device Name: | SYPHILIS HEALTH CHECK |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | DIAGNOSTICS DIRECT, LLC. 150 CHERRY LANE RD East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus DIAGNOSTICS DIRECT, LLC. 150 CHERRY LANE RD East Stroudsburg, PA 18301 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-24 |
| Decision Date | 2011-08-01 |
| Summary: | summary |