The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for First Response Gold Digital Pregnancy Test.
| Device ID | K123567 |
| 510k Number | K123567 |
| Device Name: | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Contact | Lisa Burns |
| Correspondent | Lisa Burns 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 | 2012-11-20 |
| Decision Date | 2013-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600901402 | K123567 | 000 |
| 00022600019558 | K123567 | 000 |