K843727 is an FDA 510(k) clearance for the LEUKOSTIX REAGENT STRIPS FOR URINALYSIS. 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 January 4, 1985, 102 days after receiving the submission on September 24, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7675.
| 510(k) Number | K843727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1984 |
| Decision Date | January 04, 1985 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LJX — Test, Urine Leukocyte |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.7675 |