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 | K961965 |
| 510k Number | K961965 |
| Device Name: | SURE CHECK PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Chembio Diagnostic Systems, Inc. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk Chembio Diagnostic Systems, Inc. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1996-06-24 |
| Summary: | summary |