The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Clinitek Auto 2000 Reagent Cassette (leukocytes).
| Device ID | K873304 |
| 510k Number | K873304 |
| Device Name: | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) |
| Classification | Test, Urine Leukocyte |
| 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 | LJX |
| CFR Regulation Number | 864.7675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-18 |
| Decision Date | 1987-09-11 |