K103037 is an FDA 510(k) clearance for the IND URINARY TRACT INFECTION (UTI) TEST STRIPS. This device is classified as a Test, Nitrite, Urinary, Non-quantitative, Over The Counter (Class I - General Controls, product code NGJ).
Submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on April 17, 2012, 551 days after receiving the submission on October 14, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1510.
| 510(k) Number | K103037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2010 |
| Decision Date | April 17, 2012 |
| Days to Decision | 551 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | NGJ — Test, Nitrite, Urinary, Non-quantitative, Over The Counter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1510 |