The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for Beta-tec.
| Device ID | K781794 |
| 510k Number | K781794 |
| Device Name: | BETA-TEC |
| 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 | 1978-10-25 |
| Decision Date | 1978-12-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BETA-TEC 73206087 1140136 Dead/Cancelled |
CARTER-WALLACE, INC. 1979-03-05 |
![]() BETA-TEC 73180138 1117996 Dead/Cancelled |
CARTER-WALLACE INC. 1978-07-28 |