K971976 is an FDA 510(k) clearance for the DIASCREEN REAGENT STRIPS. This device is classified as a Test, Urine Leukocyte (Class I - General Controls, product code LJX).
Submitted by Dia-Screen Corp. (Edina, US). The FDA issued a Cleared decision on June 17, 1997, 19 days after receiving the submission on May 29, 1997.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7675.
| 510(k) Number | K971976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1997 |
| Decision Date | June 17, 1997 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LJX — Test, Urine Leukocyte |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.7675 |