Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3
FDA 510(k) K040880 · Medical Analysis Systems, Inc.
510(k) numberK040880
Submission
- Device name
- Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- April 5, 2004
- Decision date
- April 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| 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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| K042717 | Mas, Dade and Liquid Assayed Diabetes ControlJJX · Traditional | 11/05/2004SE |
| K041194 | Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HJJX · Traditional | 08/16/2004SE |
| K032826 | Mas Par TDMDIF · Traditional | 10/09/2003SE |
| K032335 | Mas Cardioimmune Probnp, Mas Cardioimmune TLJJY · Traditional | 08/19/2003SE |
| K031890 | Mas Bilirubin Liquid Assayed Bilirubin ControlJJX · Traditional | 07/16/2003SE |
| K031441 | Urichemtrak Liquid Assayed Urine ControlJJW · Traditional | 07/01/2003SE |
| K031392 | Mas Tox Ammonia Controlliquid Assayed Tox Ammonia ControlDKC · Traditional | 07/01/2003SE |
| K031364 | Mas Cardiolmmune Probnp Liquid Assayed Cardiac Marker Control Level 1, 2 and 3JJY · Traditional | 05/30/2003SE |
| K030942 | Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlJJY · Traditional | 04/28/2003SE |
| K030679 | Mas Lipid Level 1 and 2JJY · Traditional | 03/14/2003SE |
Questions and answers
When was Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3 cleared by the FDA?
Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3 (K040880) received a 510(k) decision of Substantially Equivalent on April 28, 2004, 23 days after the submission was received.
What is the product code of K040880?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.