The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Plus Diabetes Monitoring Software.
| Device ID | K101371 |
| 510k Number | K101371 |
| Device Name: | ON CALL PLUS DIABETES MONITORING SOFTWARE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121 |
| Contact | Richard Lenart |
| Correspondent | Richard Lenart ACON LABORATORIES, INC. 10125 MESA RIM RD. San Diego, CA 92121 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2011-01-07 |
| Summary: | summary |