The following data is part of a premarket notification filed by Ind Diagnostic, Inc. with the FDA for Ind Urinary Tract Infection (uti) Test Strips.
| Device ID | K103037 |
| 510k Number | K103037 |
| Device Name: | IND URINARY TRACT INFECTION (UTI) TEST STRIPS |
| Classification | Test, Nitrite, Urinary, Non-quantitative, Over The Counter |
| Applicant | IND DIAGNOSTIC, INC. 1629 FOSTERS WAY Delta, B.c., CA V3m 6s7 |
| Contact | Kai Lou |
| Correspondent | Kai Lou IND DIAGNOSTIC, INC. 1629 FOSTERS WAY Delta, B.c., CA V3m 6s7 |
| Product Code | NGJ |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-14 |
| Decision Date | 2012-04-17 |