The following data is part of a premarket notification filed by International Newtech Development, Inc. with the FDA for Hcg Controls.
| Device ID | K970176 |
| 510k Number | K970176 |
| Device Name: | HCG CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | INTERNATIONAL NEWTECH DEVELOPMENT, INC. 150-13500 MAYCREST WAY Richmond, B.c., CA V6v 2n8 |
| Contact | Winnhe Wong |
| Correspondent | Winnhe Wong INTERNATIONAL NEWTECH DEVELOPMENT, INC. 150-13500 MAYCREST WAY Richmond, B.c., CA V6v 2n8 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-17 |
| Decision Date | 1997-02-06 |