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 |