The following data is part of a premarket notification filed by International Newtech Development, Inc. with the FDA for Ps-unit Cassette/serum Hcg.
| Device ID | K963133 |
| 510k Number | K963133 |
| Device Name: | PS-UNIT CASSETTE/SERUM HCG |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | INTERNATIONAL NEWTECH DEVELOPMENT, INC. 150-13500 MAYCREST WAY Richmond, B.c., CA V6v 2n8 |
| Contact | Jesse Zhu |
| Correspondent | Jesse Zhu INTERNATIONAL NEWTECH DEVELOPMENT, INC. 150-13500 MAYCREST WAY Richmond, B.c., CA V6v 2n8 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1996-11-18 |