The following data is part of a premarket notification filed by Ind Diagnostics Inc. with the FDA for Ind One Step Occult Blood (fob) Test.
| Device ID | K113506 |
| 510k Number | K113506 |
| Device Name: | IND ONE STEP OCCULT BLOOD (FOB) TEST |
| Classification | Reagent, Occult Blood |
| 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 | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-28 |
| Decision Date | 2012-12-19 |