The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Brand Name 1-step Pregnancy Test-may Be Marketed Under First Response, Answer, Or Other Brand Names.
| Device ID | K962183 |
| 510k Number | K962183 |
| Device Name: | BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 -0181 |
| Contact | Maureen Garner |
| Correspondent | Maureen Garner ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 -0181 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-06 |
| Decision Date | 1996-07-10 |
| Summary: | summary |