The following data is part of a premarket notification filed by Amerisource Pharmacal, Inc. with the FDA for One-step Pregnancy Test.
| Device ID | K031271 |
| 510k Number | K031271 |
| Device Name: | ONE-STEP PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | AMERISOURCE PHARMACAL, INC. 163 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White AMERISOURCE PHARMACAL, INC. 163 CABOT ST. Beverly, MA 01915 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-22 |
| Decision Date | 2003-06-17 |
| Summary: | summary |