The following data is part of a premarket notification filed by Mach Diag. C/o Wichita State University with the FDA for Dexpad, Blood Glucose Strip.
| Device ID | K880585 |
| 510k Number | K880585 |
| Device Name: | DEXPAD, BLOOD GLUCOSE STRIP |
| Classification | Glucose Oxidase, Glucose |
| Applicant | MACH DIAG. C/O WICHITA STATE UNIVERSITY WICHITA, KS 67208 |
| Contact | JAMES A JACKSON |
| Correspondent | JAMES A JACKSON MACH DIAG. C/O WICHITA STATE UNIVERSITY WICHITA, KS 67208 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-10 |
| Decision Date | 1988-04-18 |