Lupo-Tec
FDA 510(k) K782129 · Armkel, LLC
510(k) numberK782129
Submission
- Device name
- Lupo-Tec
- Applicant
- Armkel, LLC
Mchenry, IL, US - Received
- December 27, 1978
- Decision date
- March 12, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHC – System, Test, Systemic Lupus Erythematosus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5820
- Specialty
- Immunology
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|---|---|---|---|
| K001352 | Reaads Igg Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional | Corgenix, Inc. | 04/09/2001SE |
| K001398 | Reaads Igm Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional | Corgenix, Inc. | 03/30/2001SE |
| K930421 | Elias Dsdna AbsDHC · Traditional | Elias U.S.A., Inc. | 03/10/1993SE |
| K930247 | Human A-Ds DNA Eia Kit for Diagnostic UseDHC · Traditional | The Binding Site, Ltd. | 03/10/1993SE |
| K914801 | Immunowell Dsdna Antibody TestDHC · Traditional | General Biometrics, Inc. | 12/09/1991SE |
| K885048 | Access R-Clone Ana Profile AssayDHC · Traditional | Lipogen, Inc. | 01/24/1989SE |
| K872910 | Immuno/SleDHC · Traditional | Immunostics Co., Inc. | 08/12/1987SE |
| K821385 | Sero/Tex Le TestDHC · Traditional | Texas Immunology, Inc. | 05/28/1982SE |
| K810981 | Anti Ndna Immunoflourescent Test SysDHC · Traditional | Immuno-Products Industries | 04/29/1981SE |
| K810226 | Sle Anti-N-Dna Latex TestDHC · Traditional | Icl Scientific | 02/09/1981SE |
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| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
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Questions and answers
When was Lupo-Tec cleared by the FDA?
Lupo-Tec (K782129) received a 510(k) decision of Substantially Equivalent on March 12, 1979, 75 days after the submission was received.
What is the product code of K782129?
The FDA product code is DHC – System, Test, Systemic Lupus Erythematosus, a Class II (moderate risk) device regulated under 21 CFR 866.5820.