The Gamma-B Anti-Ds DNA Kit & Optional Controls
FDA 510(k) K872085 · Immunodiagnostics, Ltd.
510(k) numberK872085
Submission
- Device name
- The Gamma-B Anti-Ds DNA Kit & Optional Controls
- Applicant
- Immunodiagnostics, Ltd.
England, U.K., GB - Received
- June 1, 1987
- Decision date
- September 1, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LSW – Anti-Dna Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit…LSW · Traditional | Aesku.Diagnostics GmbH & Co. KG | 02/16/2018SE |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsLSW · Traditional | Inova Diagnostics, Inc. | 04/11/2016SE |
| K081251 | Modification to Aeskulisa DS DNA GLSW · Special | Aesku Diagnostics | 05/13/2008SE |
| K072393 | Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01LSW · Traditional | Phadia US, Inc. | 12/07/2007SE |
| K060380 | Fidis DsdnaLSW · Traditional | Biomedical Diagnostics (Bmd) SA | 05/02/2006SE |
| K041628 | Aeskulisa DS DNA GLSW · Traditional | Aesku Diagnostics | 10/14/2004SE |
| K921658 | Anti-Dsdna Antibody TestLSW · Traditional | Immco Diagnostics, Inc. | 03/22/1993SE |
Questions and answers
When was The Gamma-B Anti-Ds DNA Kit & Optional Controls cleared by the FDA?
The Gamma-B Anti-Ds DNA Kit & Optional Controls (K872085) received a 510(k) decision of Substantially Equivalent on September 1, 1987, 92 days after the submission was received.
What is the product code of K872085?
The FDA product code is LSW – Anti-Dna Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.