The following data is part of a premarket notification filed by Home Diagnostics, Inc. with the FDA for Dialet Lancing Device.
| Device ID | K861265 |
| 510k Number | K861265 |
| Device Name: | DIALET LANCING DEVICE |
| Classification | Lancet, Blood |
| Applicant | HOME DIAGNOSTICS, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Jerry B Slaven |
| Correspondent | Jerry B Slaven HOME DIAGNOSTICS, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-04 |
| Decision Date | 1986-04-30 |