Sle Anti-N-Dna Latex Test
FDA 510(k) K810226 · Icl Scientific
510(k) numberK810226
Submission
- Device name
- Sle Anti-N-Dna Latex Test
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- January 27, 1981
- Decision date
- February 9, 1981
- 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
Other 510(k)s with product code DHC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K800992 | Cordia NPDHC · Traditional | Cordis Corp. | 05/08/1980SE |
More from Cordis Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | 11/29/1982SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
Questions and answers
When was Sle Anti-N-Dna Latex Test cleared by the FDA?
Sle Anti-N-Dna Latex Test (K810226) received a 510(k) decision of Substantially Equivalent on February 9, 1981, 13 days after the submission was received.
What is the product code of K810226?
The FDA product code is DHC – System, Test, Systemic Lupus Erythematosus, a Class II (moderate risk) device regulated under 21 CFR 866.5820.