Triage Cardiac Controls; Triage Cardio Profiler Controls
FDA 510(k) K030089 · Biosite Incorporated
510(k) numberK030089
Submission
- Device name
- Triage Cardiac Controls; Triage Cardio Profiler Controls
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- January 10, 2003
- Decision date
- January 23, 2003
- 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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| 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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| K093032 | Triage Total 3 Controls and Calibration Verification SetJJY · Traditional | 11/13/2009SE |
| K080269 | Triage Cardioprofiler and Profiler S.O.B. PanelsNBC · Traditional | 06/06/2008SE |
| K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5JJY · Traditional | 12/07/2007SE |
| K062840 | Triage Protein C Controls and Calibration Verification ControlsGGN · Traditional | 03/01/2007SE |
| K062530 | Triage Protein C TestGGP · Traditional | 01/29/2007SE |
| K060788 | Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414DIF · Traditional | 07/10/2006SE |
| K060791 | Triage Tox Drug Screen, Model 94400DJR · Traditional | 06/22/2006SE |
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Questions and answers
When was Triage Cardiac Controls; Triage Cardio Profiler Controls cleared by the FDA?
Triage Cardiac Controls; Triage Cardio Profiler Controls (K030089) received a 510(k) decision of Substantially Equivalent on January 23, 2003, 13 days after the submission was received.
What is the product code of K030089?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.