QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
FDA 510(k) K152013 · Inova Diagnostics, Inc.
510(k) numberK152013
Submission
- Device name
- QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- July 21, 2015
- Decision date
- April 11, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K872085 | The Gamma-B Anti-Ds DNA Kit & Optional ControlsLSW · Traditional | Immunodiagnostics, Ltd. | 09/01/1987SE |
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| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | 12/11/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
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Questions and answers
When was QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls cleared by the FDA?
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls (K152013) received a 510(k) decision of Substantially Equivalent on April 11, 2016, 265 days after the submission was received.
What is the product code of K152013?
The FDA product code is LSW – Anti-Dna Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.