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.
| Device ID | K123436 |
| 510k Number | K123436 |
| Device Name: | FIRST RESPONSE EARLY RESULT PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Contact | Joseph Ciccone |
| Correspondent | Joseph Ciccone 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 | 2012-11-07 |
| Decision Date | 2013-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00061700900700 | K123436 | 000 |
| 80022600999641 | K123436 | 000 |
| 80022600020208 | K123436 | 000 |
| 00022600901273 | K123436 | 000 |
| 00022600901259 | K123436 | 000 |
| 00022600020141 | K123436 | 000 |
| 80022600901255 | K123436 | 000 |