The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Glucostix Reagent Strips & Glucometer Reflect-phot.
| Device ID | K851703 |
| 510k Number | K851703 |
| Device Name: | GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT |
| Classification | Glucose Oxidase, Glucose |
| Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Contact | John H Englemann |
| Correspondent | John H Englemann MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-24 |
| Decision Date | 1985-08-23 |