K950307 is an FDA 510(k) clearance for the BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on March 1, 1995, 35 days after receiving the submission on January 25, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K950307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 1995 |
| Decision Date | March 01, 1995 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |