The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Test Urobilinogen In Urine & Leukocytes In Urine.
| Device ID | K852611 |
| 510k Number | K852611 |
| Device Name: | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE |
| Classification | Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) |
| Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Contact | John H Engelmann |
| Correspondent | John H Engelmann MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Product Code | CDM |
| CFR Regulation Number | 862.1785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-19 |
| Decision Date | 1985-09-03 |