K853141 is an FDA 510(k) clearance for the ACCESS DIGIWIPE SYSTEM. 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 November 18, 1985, 117 days after receiving the submission on July 24, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K853141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1985 |
| Decision Date | November 18, 1985 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | KHE - Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |