K854059 is an FDA 510(k) clearance for the MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Bioclinical Systems, Inc. (St.Louis, US). The FDA issued a Cleared decision on January 13, 1986, 102 days after receiving the submission on October 3, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K854059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1985 |
| Decision Date | January 13, 1986 |
| Days to Decision | 102 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 |