The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Gio. De Vita E C. S.r.l.(gdv) Automatic Washing System.
| Device ID | K962687 |
| 510k Number | K962687 |
| Device Name: | GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Contact | Dave D Smith |
| Correspondent | Dave D Smith NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-11 |
| Decision Date | 1997-03-28 |