The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Clinitek 10 Semi-auto Urinalysis Sys.
| Device ID | K842238 |
| 510k Number | K842238 |
| Device Name: | CLINITEK 10 SEMI-AUTO URINALYSIS SYS |
| Classification | Automated Urinalysis System |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-05 |
| Decision Date | 1984-07-25 |