The following data is part of a premarket notification filed by Orient Gene Biotech with the FDA for Fob One Step Rapid Test.
| Device ID | K110309 |
| 510k Number | K110309 |
| Device Name: | FOB ONE STEP RAPID TEST |
| Classification | Reagent, Occult Blood |
| Applicant | ORIENT GENE BIOTECH 150 CHERRY LANE RD East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus ORIENT GENE BIOTECH 150 CHERRY LANE RD East Stroudsburg, PA 18301 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-02 |
| Decision Date | 2011-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816490021159 | K110309 | 000 |
| 00850011007167 | K110309 | 000 |
| 00850011007150 | K110309 | 000 |
| 00722066004999 | K110309 | 000 |
| 00722066004746 | K110309 | 000 |