The following data is part of a premarket notification filed by Excel Scientific, Inc. with the FDA for Ez Sure Onestep Early Pregnancy Test.
| Device ID | K962580 |
| 510k Number | K962580 |
| Device Name: | EZ SURE ONESTEP EARLY PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE. Yorba Linda, CA 92887 |
| Contact | Min-lee Cheng, Ph.d. |
| Correspondent | Min-lee Cheng, Ph.d. EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE. Yorba Linda, CA 92887 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1996-08-29 |
| Summary: | summary |