The following data is part of a premarket notification filed by International Newtech Development, Inc. with the FDA for One Step Midstream Hcg Pregnancy Test.
| Device ID | K974059 |
| 510k Number | K974059 |
| Device Name: | ONE STEP MIDSTREAM HCG PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | INTERNATIONAL NEWTECH DEVELOPMENT, INC. 1629 FOSTERS WAY Delta, British Columbia, CA V3m 6s7 |
| Contact | Benny Wang |
| Correspondent | Benny Wang INTERNATIONAL NEWTECH DEVELOPMENT, INC. 1629 FOSTERS WAY Delta, British Columbia, CA V3m 6s7 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-27 |
| Decision Date | 1998-04-09 |