The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Glucoscan Controls.
| Device ID | K822698 |
| 510k Number | K822698 |
| Device Name: | GLUCOSCAN CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | LIFESCAN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-07 |
| Decision Date | 1982-09-30 |