Audit MicroControls Linearity FD Tumor Markers II
FDA 510(k) K143573 · Aalto Scientific, Ltd.
510(k) numberK143573
Submission
- Device name
- Audit MicroControls Linearity FD Tumor Markers II
- Applicant
- Aalto Scientific, Ltd.
Carlsbad, CA, US - Received
- December 17, 2014
- Decision date
- January 16, 2015
- 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
Other 510(k)s with product code JJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K133676 | Abx Pentra Micro Alb Control L/HJJY · Abbreviated | Horiba Abx SAS | 07/11/2014SE |
More from Horiba Abx SAS
| 510(k) | Device | Decision |
|---|---|---|
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | 03/10/2017SE |
| K161874 | Audit MicroControls Linearity DROP LQ Blood GlucoseJJX · Traditional | 08/10/2016SE |
| K143571 | Audit MicroControls Linearity LQ Cystatin-CJJX · Traditional | 01/23/2015SE |
| K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityJJX · Traditional | 11/21/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | 11/20/2014SE |
| K130762 | Audit Microcv Therapeutic Drug (TDM) Linearity SetJJY · Traditional | 04/29/2013SE |
| K130764 | Audit Microcv Vitamin D Linearity SetJJX · Traditional | 04/26/2013SE |
| K130157 | Audit Microcv Beta-Hydroxybutyric Acid Linearity SetJJX · Traditional | 03/19/2013SE |
| K112742 | Audit Microlq Spinal Fluid ControlJJY · Traditional | 06/15/2012SE |
| K111964 | Audit Microcv Urine/Fluids Chemistry LinearityJJY · Traditional | 03/02/2012SE |
Questions and answers
When was Audit MicroControls Linearity FD Tumor Markers II cleared by the FDA?
Audit MicroControls Linearity FD Tumor Markers II (K143573) received a 510(k) decision of Substantially Equivalent on January 16, 2015, 30 days after the submission was received.
What is the product code of K143573?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.