The following data is part of a premarket notification filed by Biomedical Research & Development Laboratories Inc with the FDA for H.p.t. Home Preg. Test Kit & A.p.t..
| Device ID | K834474 |
| 510k Number | K834474 |
| Device Name: | H.P.T. HOME PREG. TEST KIT & A.P.T. |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BIOMEDICAL RESEARCH & DEVELOPMENT LABORATORIES INC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-20 |
| Decision Date | 1984-09-28 |