The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Reagent Strips For Urinalysis.
| Device ID | K811342 |
| 510k Number | K811342 |
| Device Name: | REAGENT STRIPS FOR URINALYSIS |
| Classification | Refractometer For Clinical Use |
| Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Product Code | JRE |
| CFR Regulation Number | 862.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-12 |
| Decision Date | 1981-09-01 |