The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Digiflex Automatic Pipette.
| Device ID | K830157 |
| 510k Number | K830157 |
| Device Name: | DIGIFLEX AUTOMATIC PIPETTE |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | MICROMEDIC SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-03-10 |