K874849 is an FDA 510(k) clearance for the PROSPECT/GIARDIA. This device is classified as a Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (Class II - Special Controls, product code KHW).
Submitted by Alexon Biomedical, Inc. (Glen Ellyn, US). The FDA issued a Cleared decision on January 5, 1988, 41 days after receiving the submission on November 25, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3220.
| 510(k) Number | K874849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1987 |
| Decision Date | January 05, 1988 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KHW — Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3220 |