K843601 is an FDA 510(k) clearance for the ACCESS HEMAWIPE. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Medtech Products, Inc. (Miami, US). The FDA issued a Cleared decision on January 4, 1985, 114 days after receiving the submission on September 12, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K843601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 1984 |
| Decision Date | January 04, 1985 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | - |
| Product Code | KHE - Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |