The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Unilet Lancet.
| Device ID | K842517 |
| 510k Number | K842517 |
| Device Name: | UNILET LANCET |
| Classification | Chair, Blood Donor |
| Applicant | ULSTER SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FML |
| CFR Regulation Number | 880.6140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1984-09-20 |