K873033 is an FDA 510(k) clearance for the HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on September 14, 1987, 41 days after receiving the submission on August 4, 1987.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K873033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1987 |
| Decision Date | September 14, 1987 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |