K862108 is an FDA 510(k) clearance for the ENZYMUN-TEST HCG. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 19, 1986, 77 days after receiving the submission on June 3, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K862108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1986 |
| Decision Date | August 19, 1986 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |