The following data is part of a premarket notification filed by Armkel Llc with the FDA for First Response One-step Digital Pregnancy Test.
| Device ID | K040866 |
| 510k Number | K040866 |
| Device Name: | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ARMKEL LLC 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Contact | Stephen C Kolakowsky |
| Correspondent | Stephen C Kolakowsky ARMKEL LLC 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 | 2004-04-02 |
| Decision Date | 2004-10-19 |
| Summary: | summary |