The following data is part of a premarket notification filed by Connecticut Diagnostics, Ltd. with the FDA for Visi-staph.
| Device ID | K905617 |
| 510k Number | K905617 |
| Device Name: | VISI-STAPH |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | CONNECTICUT DIAGNOSTICS, LTD. 36C BEATRICE AVE. Danielson, CT 06239 |
| Contact | John Abraham |
| Correspondent | John Abraham CONNECTICUT DIAGNOSTICS, LTD. 36C BEATRICE AVE. Danielson, CT 06239 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-14 |
| Decision Date | 1991-03-29 |