The following data is part of a premarket notification filed by Ml Strategies, Inc. with the FDA for Human Chorionic Gonadotropin (hcg) Test System For The Early Detection Of Pregnancy.
| Device ID | K950354 |
| 510k Number | K950354 |
| Device Name: | HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ML STRATEGIES, INC. ONE FINANCIAL CENTER BOSTON, MA 02111 |
| Contact | CAROLYN S LANGER |
| Correspondent | CAROLYN S LANGER ML STRATEGIES, INC. ONE FINANCIAL CENTER BOSTON, MA 02111 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-30 |
| Decision Date | 1995-07-19 |