Advia Ims Cpsa Control
FDA 510(k) K061137 · Bayer Healthcare, LLC
510(k) numberK061137
Submission
- Device name
- Advia Ims Cpsa Control
- Applicant
- Bayer Healthcare, LLC
Tarrytown, NY, US - Received
- April 24, 2006
- Decision date
- July 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
|---|---|---|
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)NUH · Traditional | 03/07/2018SE |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)NUH · Traditional | 12/22/2015SE |
| K150942 | Contour Next USB Blood Glucose Monitoring SystemNBW · Special | 11/25/2015SE |
| K151742 | Contour Next Control SolutionJJX · Traditional | 09/23/2015SE |
| K130265 | Contour Next Ez Blood Glucose MeterNBW · Traditional | 06/23/2014SE |
| K122370 | Contour Next Link Wireless Blood Glucose MonitorNBW · Traditional | 09/26/2013SE |
| K121190 | Contour Next Blood Glucose MeterLFR · Special | 07/26/2012SE |
| K121087 | Contour Next Usb Blood Glucose Monitoring SystemNBW · Special | 06/28/2012SE |
| K110894 | Contour Next Link Wireless Blood Glucose MeterLFR · Traditional | 03/28/2012SE |
| K110587 | Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…LFR · Traditional | 03/28/2012SE |
Questions and answers
When was Advia Ims Cpsa Control cleared by the FDA?
Advia Ims Cpsa Control (K061137) received a 510(k) decision of Substantially Equivalent on July 6, 2006, 73 days after the submission was received.
What is the product code of K061137?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.