The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Platform Onestep Pregnancy Home Test.
| Device ID | K960117 |
| 510k Number | K960117 |
| Device Name: | PLATFORM ONESTEP PREGNANCY HOME TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST Carlsbad, CA 92008 |
| Contact | Charles Yu |
| Correspondent | Charles Yu SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST Carlsbad, CA 92008 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-03-19 |
| Summary: | summary |