The following data is part of a premarket notification filed by Metrika, Inc. with the FDA for Drx Qt. Hcg.
| Device ID | K991532 |
| 510k Number | K991532 |
| Device Name: | DRX QT. HCG |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022 |
| Contact | Ya-chen Hsu |
| Correspondent | Ya-chen Hsu METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 1999-09-17 |
| Summary: | summary |