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 |