Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls,
FDA 510(k) K123593 · Inova Diagnostics, Inc.
510(k) numberK123593
Submission
- Device name
- Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls,
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- November 21, 2012
- Decision date
- April 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKP – Anti-Sm Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202067 | EliA SmDP-SLKP · Traditional | Phadia AB | 07/14/2021SE |
| K183007 | EliA SmDP ImmunoassayLKP · Traditional | Phadia AB | 12/24/2018SE |
| K132631 | Eia SMDP ImmunoassayLKP · Traditional | Phadia US, Inc. | 08/29/2014SE |
| K051066 | Theratest El-Ana ProfilesLKP · Traditional | Theratest Laboratories, Inc. | 10/07/2005SE |
| K042629 | Varelisa SM Antibodies, Model 18296LKP · Traditional | Sweden Diagnostics (Germany) GmbH | 12/08/2004SE |
| K024219 | Liquichek Anti-Sm Control, Positive, Catalog #115LKP · Traditional | Bio-Rad | 01/15/2003SE |
| K013263 | Fred Hutchinson Cancer Research Center Enzyme Anti-Sr Protein Antibody TestLKP · Traditional | Fred Hutchinson Cancer Research Center | 07/29/2002SE |
| K000755 | Rhigene MESACUP2 Test- SMLKP · Traditional | Rhigene, Inc. | 05/09/2000SE |
| K000312 | Varelisa SM AntibodiesLKP · Traditional | Pharmacia & Upjohn Co. | 03/17/2000SE |
| K990625 | Autostat II Anti-Sm ElisaLKP · Traditional | Cogent Diagnotics , Ltd. | 04/28/1999SE |
More from Cogent Diagnotics , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K243979 | Aptiva APS IgA ReagentMSV · Traditional | 02/06/2026SE |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID · Traditional | 12/17/2024SE |
| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | 09/29/2023SE |
| K200230 | Aptiva Celiac Disease IgG ReagentMVM · Traditional | 08/26/2021SE |
| K193604 | Aptiva Celiac Disease IgA ReagentMVM · Traditional | 06/16/2021SE |
| 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 |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…NXO · Traditional | 12/22/2017SE |
Questions and answers
When was Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls, cleared by the FDA?
Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls, (K123593) received a 510(k) decision of Substantially Equivalent on April 17, 2013, 147 days after the submission was received.
What is the product code of K123593?
The FDA product code is LKP – Anti-Sm Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.