K003856 is an FDA 510(k) clearance for the EZ-HCG URINE(PREGNANCY TEST). This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on February 21, 2001, 70 days after receiving the submission on December 13, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K003856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2000 |
| Decision Date | February 21, 2001 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHI - Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |