K070660 is an FDA 510(k) clearance for the INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Alfa Scientific Designs, Inc. (Powat, US). The FDA issued a Cleared decision on June 21, 2007, 104 days after receiving the submission on March 9, 2007.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K070660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2007 |
| Decision Date | June 21, 2007 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KHE — Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |