The following data is part of a premarket notification filed by Diesse Diagnostica Senese S.p.a with the FDA for Enzy-well Syphilis Igg, Model 91106.
| Device ID | K050590 |
| 510k Number | K050590 |
| Device Name: | ENZY-WELL SYPHILIS IGG, MODEL 91106 |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | DIESSE DIAGNOSTICA SENESE S.P.A 555 NE 34TH ST #1905 Miami, FL 33137 |
| Contact | Gloria Schlanser |
| Correspondent | Gloria Schlanser DIESSE DIAGNOSTICA SENESE S.P.A 555 NE 34TH ST #1905 Miami, FL 33137 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-08 |
| Decision Date | 2006-08-10 |
| Summary: | summary |