The following data is part of a premarket notification filed by Ind Diagnostic Inc. with the FDA for Ind One Step Fecal Occult Blood Test Model 440-10.
| Device ID | K100031 |
| 510k Number | K100031 |
| Device Name: | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 |
| Classification | Reagent, Occult Blood |
| Applicant | IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, Bc, CA V3m 6s7 |
| Contact | Jason Peng |
| Correspondent | Jason Peng IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, Bc, CA V3m 6s7 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-06 |
| Decision Date | 2010-07-19 |