Immuno/Sle
FDA 510(k) K872910 · Immunostics Co., Inc.
510(k) numberK872910
Submission
- Device name
- Immuno/Sle
- Applicant
- Immunostics Co., Inc.
Ocean, NJ, US - Received
- July 24, 1987
- Decision date
- August 12, 1987
- 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 |
| 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 |
| K800992 | Cordia NPDHC · Traditional | Cordis Corp. | 05/08/1980SE |
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Questions and answers
When was Immuno/Sle cleared by the FDA?
Immuno/Sle (K872910) received a 510(k) decision of Substantially Equivalent on August 12, 1987, 19 days after the submission was received.
What is the product code of K872910?
The FDA product code is DHC – System, Test, Systemic Lupus Erythematosus, a Class II (moderate risk) device regulated under 21 CFR 866.5820.