K042676 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on December 17, 2004, 79 days after receiving the submission on September 29, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K042676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2004 |
| Decision Date | December 17, 2004 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |