The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for First Response 5 Minute Pregnancy Test.
| Device ID | K874823 |
| 510k Number | K874823 |
| Device Name: | FIRST RESPONSE 5 MINUTE PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Contact | Staab, Phd |
| Correspondent | Staab, Phd TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-24 |
| Decision Date | 1988-04-05 |