The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for First Response Pregnancy Test.
| Device ID | K030258 |
| 510k Number | K030258 |
| Device Name: | FIRST RESPONSE PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ARMKEL, LLC. 469 NORTH HARRISON ST. Princeton, NJ 08540 -3510 |
| Contact | Stephen C Kolakowsky |
| Correspondent | Stephen C Kolakowsky ARMKEL, LLC. 469 NORTH HARRISON ST. Princeton, NJ 08540 -3510 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-24 |
| Decision Date | 2003-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600998631 | K030258 | 000 |
| 00022600408123 | K030258 | 000 |