The following data is part of a premarket notification filed by Chembio Diagnostic Systems, Inc. with the FDA for Sure Check Pregnancy Test.
| Device ID | K011551 |
| 510k Number | K011551 |
| Device Name: | SURE CHECK PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Chembio Diagnostic Systems, Inc. 163 CABOT ST. Beverly,, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White Chembio Diagnostic Systems, Inc. 163 CABOT ST. Beverly,, MA 01915 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-18 |
| Decision Date | 2001-08-14 |