K974059 is an FDA 510(k) clearance for the ONE STEP MIDSTREAM HCG PREGNANCY TEST. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by International Newtech Development, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on April 9, 1998, 164 days after receiving the submission on October 27, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K974059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1997 |
| Decision Date | April 09, 1998 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |