K863861 is an FDA 510(k) clearance for the TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 1986, 49 days after receiving the submission on October 3, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K863861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1986 |
| Decision Date | November 21, 1986 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |