The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for First Response(r) One-step.
| Device ID | K914304 |
| 510k Number | K914304 |
| Device Name: | FIRST RESPONSE(R) ONE-STEP |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | C Kolakowsky |
| Correspondent | C Kolakowsky ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-25 |
| Decision Date | 1991-10-17 |