The following data is part of a premarket notification filed by Palco Laboratories, Inc. with the FDA for Auto-lancet.
| Device ID | K833344 |
| 510k Number | K833344 |
| Device Name: | AUTO-LANCET |
| Classification | Lancet, Blood |
| Applicant | PALCO LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-27 |
| Decision Date | 1983-11-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AUTO-LANCET 73770322 not registered Dead/Abandoned |
LEVIN, PAUL D. 1988-12-19 |
![]() AUTO-LANCET 73495414 not registered Dead/Abandoned |
LEVIN, PAUL D. 1984-08-17 |