The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Fecal Occult Blood (fob) Rapid Test.
| Device ID | K070660 |
| 510k Number | K070660 |
| Device Name: | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST |
| Classification | Reagent, Occult Blood |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Contact | Majid Pajouh |
| Correspondent | Majid Pajouh ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. Poway, CA 92064 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-09 |
| Decision Date | 2007-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M52550640 | K070660 | 000 |
| M52550631 | K070660 | 000 |
| M52550621 | K070660 | 000 |
| M52550611 | K070660 | 000 |