Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel Minipak
FDA 510(k) K123663 · Bio-Rad Laboratories
510(k) numberK123663
Submission
- Device name
- Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel Minipak
- Applicant
- Bio-Rad Laboratories
Irvine, CA, US - Received
- November 28, 2012
- Decision date
- December 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
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| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | 01/10/2017SE |
| K161687 | D-10 Hemoglobin A1c ProgramPDJ · Traditional | 10/14/2016SE |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level…PMN · Traditional | 05/10/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | 12/11/2015SE |
Questions and answers
When was Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel Minipak cleared by the FDA?
Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel Minipak (K123663) received a 510(k) decision of Substantially Equivalent on December 27, 2012, 29 days after the submission was received.
What is the product code of K123663?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.