The following data is part of a premarket notification filed by Micropoint Technologies Pte Ltd with the FDA for Plancet.
| Device ID | K113513 |
| 510k Number | K113513 |
| Device Name: | PLANCET |
| Classification | Lancet, Blood |
| Applicant | MICROPOINT TECHNOLOGIES PTE LTD 11, KALLANG PLACE #06-10/12 Singapore, SG 339155 |
| Contact | Chee Y Lim |
| Correspondent | Chee Y Lim MICROPOINT TECHNOLOGIES PTE LTD 11, KALLANG PLACE #06-10/12 Singapore, SG 339155 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-28 |
| Decision Date | 2012-07-13 |
| Summary: | summary |