Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls
FDA 510(k) K030088 · Biosite Incorporated
510(k) numberK030088
Submission
- Device name
- Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- January 10, 2003
- Decision date
- January 17, 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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| 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 |
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Questions and answers
When was Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls cleared by the FDA?
Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls (K030088) received a 510(k) decision of Substantially Equivalent on January 17, 2003, 7 days after the submission was received.
What is the product code of K030088?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.