The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Leukostix Reagent Strips For Urinalysis.
| Device ID | K843727 |
| 510k Number | K843727 |
| Device Name: | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS |
| Classification | Test, Urine Leukocyte |
| Applicant | MILES LABORATORIES, INC. P.O. BOX 40 Elkhart, IN 46515 |
| Contact | John Englemann |
| Correspondent | John Englemann MILES LABORATORIES, INC. P.O. BOX 40 Elkhart, IN 46515 |
| Product Code | LJX |
| CFR Regulation Number | 864.7675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-24 |
| Decision Date | 1985-01-04 |