The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (h-hcg) Assay.
| Device ID | K042676 |
| 510k Number | K042676 |
| Device Name: | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
| Contact | Xie Qiyl |
| Correspondent | Alfredo Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES 1500 CAPITOL AVENUE MAILSTOP 7602 Sacramento, CA 95814 |
| Product Code | DHA |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-29 |
| Decision Date | 2004-12-17 |
| Summary: | summary |