The following data is part of a premarket notification filed by Ind Diagnostics Inc. with the FDA for Ind One Step Hcg Urine Pregnancy Test (strip).
| Device ID | K110889 |
| 510k Number | K110889 |
| Device Name: | IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | IND DIAGNOSTICS INC. 1629 FOSTERS WAY Delta, British Columbia, CA V3m 6s7 |
| Contact | Kai Lou |
| Correspondent | Kai Lou IND DIAGNOSTICS INC. 1629 FOSTERS WAY Delta, British Columbia, CA V3m 6s7 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-30 |
| Decision Date | 2011-06-20 |