The following data is part of a premarket notification filed by New Bay Bioresearch Co. Ltd. with the FDA for Forsure One Step Fecal Occult Blood (fob) Screen Card Test.
| Device ID | K063693 |
| 510k Number | K063693 |
| Device Name: | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST |
| Classification | Reagent, Occult Blood |
| Applicant | NEW BAY BIORESEARCH CO. LTD. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Contact | Rodrigo Berlie |
| Correspondent | Rodrigo Berlie NEW BAY BIORESEARCH CO. LTD. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10748349000080 | K063693 | 000 |
| 10748349000073 | K063693 | 000 |
| 30748349000022 | K063693 | 000 |
| 10763924607058 | K063693 | 000 |
| 10763924632500 | K063693 | 000 |
| 10763924630551 | K063693 | 000 |
| 10763924625250 | K063693 | 000 |
| 10763924620552 | K063693 | 000 |
| 10763924612250 | K063693 | 000 |