Modification to Quantimetrix Cardiasure Cardiac Marker
FDA 510(k) K062751 · Quantimetrix Corp.
510(k) numberK062751
Submission
- Device name
- Modification to Quantimetrix Cardiasure Cardiac Marker
- Applicant
- Quantimetrix Corp.
Redondo Beach, CA, US - Received
- September 14, 2006
- Decision date
- October 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K993723 | Cardiasure Cardiac Markers ControlJJT · Traditional | Quantimetrix Corp. | 11/23/1999SE |
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| K984437 | Quantex Aso-Crp-Rp Control IIJJT · Traditional | Instrumentation Laboratory CO | 02/02/1999SE |
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Questions and answers
When was Modification to Quantimetrix Cardiasure Cardiac Marker cleared by the FDA?
Modification to Quantimetrix Cardiasure Cardiac Marker (K062751) received a 510(k) decision of Substantially Equivalent on October 3, 2006, 19 days after the submission was received.
What is the product code of K062751?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.