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 |