Mas Cardioimmune TL Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac TL Low Level Liquid Assayed Cardiac Ma
FDA 510(k) K023669 · Medical Analysis Systems, Inc.
510(k) numberK023669
Submission
- Device name
- Mas Cardioimmune TL Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac TL Low Level Liquid Assayed Cardiac Ma
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- October 31, 2002
- Decision date
- December 19, 2002
- 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
Other 510(k)s with product code JJY
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|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| 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 |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K040880 | Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3JJY · Traditional | 04/28/2004SE |
| 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 |
Questions and answers
When was Mas Cardioimmune TL Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac TL Low Level Liquid Assayed Cardiac Ma cleared by the FDA?
Mas Cardioimmune TL Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac TL Low Level Liquid Assayed Cardiac Ma (K023669) received a 510(k) decision of Substantially Equivalent on December 19, 2002, 49 days after the submission was received.
What is the product code of K023669?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.