The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for First Response Early Result Pregnancy Test (otc).
| Device ID | K083716 |
| 510k Number | K083716 |
| Device Name: | FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Contact | Stephen C Kolakowsky |
| Correspondent | Stephen C Kolakowsky CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-06-08 |
| Summary: | summary |