K873304 is an FDA 510(k) clearance for the CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES). This device is classified as a Test, Urine Leukocyte (Class I - General Controls, product code LJX).
Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on September 11, 1987, 24 days after receiving the submission on August 18, 1987.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7675.
| 510(k) Number | K873304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1987 |
| Decision Date | September 11, 1987 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | LJX — Test, Urine Leukocyte |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.7675 |