K020968 is an FDA 510(k) clearance for the LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Pan Probe Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 15, 2002, 111 days after receiving the submission on March 26, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K020968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2002 |
| Decision Date | July 15, 2002 |
| Days to Decision | 111 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 |