The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Eskaflow Test For Glucose.
| Device ID | K811849 |
| 510k Number | K811849 |
| Device Name: | ESKAFLOW TEST FOR GLUCOSE |
| Classification | Hexokinase, Glucose |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-15 |