K854619 is an FDA 510(k) clearance for the DETECTACULT. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Immunostics Co., Inc. (Metuchen, US). The FDA issued a Cleared decision on March 3, 1986, 105 days after receiving the submission on November 18, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K854619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1985 |
| Decision Date | March 03, 1986 |
| Days to Decision | 105 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 |