The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for Biocept-g.
| Device ID | K760336 |
| 510k Number | K760336 |
| Device Name: | BIOCEPT-G |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | WAMPOLE LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-30 |
| Decision Date | 1976-11-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOCEPT-G 73109896 1072975 Dead/Expired |
CARTER-WALLACE, INC. 1976-12-17 |