The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Mpx System, Glucose Test System.
| Device ID | K864322 |
| 510k Number | K864322 |
| Device Name: | MPX SYSTEM, GLUCOSE TEST SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | LIFESCAN, INC. 2443 WYANDOTTE ST. Mountain View, CA 94043 |
| Contact | Duff Self |
| Correspondent | Duff Self LIFESCAN, INC. 2443 WYANDOTTE ST. Mountain View, CA 94043 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-03 |
| Decision Date | 1987-02-25 |