K842660 is an FDA 510(k) clearance for the ANTI-SCHISTOSOMA SPECIES KIT. This device is classified as a Antigen, Fluorescent Antibody Test, Schistosoma Mansoni (Class I - General Controls, product code GNH).
Submitted by Amico Lab, Inc.. The FDA issued a Cleared decision on October 30, 1984, 112 days after receiving the submission on July 10, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3600.
| 510(k) Number | K842660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1984 |
| Decision Date | October 30, 1984 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GNH — Antigen, Fluorescent Antibody Test, Schistosoma Mansoni |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3600 |