K020439 is an FDA 510(k) clearance for the STATUS HCG SERUM/URINE. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 23, 2002, 101 days after receiving the submission on February 11, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K020439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2002 |
| Decision Date | May 23, 2002 |
| Days to Decision | 101 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 |