The following data is part of a premarket notification filed by Saliva Diagnostic Systems with the FDA for Evidence Pregnancy Test.
| Device ID | K962721 |
| 510k Number | K962721 |
| Device Name: | EVIDENCE PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SALIVA DIAGNOSTIC SYSTEMS 15 OAK STREET, SUITE 3 Beverly Farms, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White SALIVA DIAGNOSTIC SYSTEMS 15 OAK STREET, SUITE 3 Beverly Farms, MA 01915 |
| Product Code | LCX |
| Subsequent Product Code | JHI |
| Subsequent Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-15 |
| Decision Date | 1996-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868926000326 | K962721 | 000 |