The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Chosen Lancing Device.
| Device ID | K113332 |
| 510k Number | K113332 |
| Device Name: | ON CALL CHOSEN LANCING DEVICE |
| Classification | Lancet, Blood |
| Applicant | ACON LABORATORIES, INC. 10125 MESA RIM ROAD San Diego, CA 92121 |
| Contact | Aaron Friday |
| Correspondent | Aaron Friday ACON LABORATORIES, INC. 10125 MESA RIM ROAD San Diego, CA 92121 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2012-04-18 |
| Summary: | summary |