The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Lupo-tec.
Device ID | K782129 |
510k Number | K782129 |
Device Name: | LUPO-TEC |
Classification | System, Test, Systemic Lupus Erythematosus |
Applicant | ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DHC |
CFR Regulation Number | 866.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-27 |
Decision Date | 1979-03-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LUPO-TEC 73146998 1099119 Dead/Expired |
CARTER-WALLACE, INC. 1977-12-29 |