Cardiasure Cardiac Markers Control
FDA 510(k) K993723 · Quantimetrix Corp.
510(k) numberK993723
Submission
- Device name
- Cardiasure Cardiac Markers Control
- Applicant
- Quantimetrix Corp.
Redondo Beach, CA, US - Received
- November 3, 1999
- Decision date
- November 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code JJT
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|---|---|---|---|
| K090940 | Spotcheck Blood Spot Control, AssayedJJT · Traditional | Astoria-Pacific, Inc. | 12/14/2009SE |
| K062751 | Modification to Quantimetrix Cardiasure Cardiac MarkerJJT · Special | Quantimetrix Corp. | 10/03/2006SE |
| K030768 | Cliniqa Liquid QC Cardiac Marker Control Levels 1, 2 & 3, Tri-LevelJJT · Traditional | Cliniqa Corporation | 03/21/2003SE |
| K030102 | Advia Centaur and ACS:180 Liquid Cardiac Markers 1, 2, 3JJT · Abbreviated | Bayer Healthcare, LLC | 01/24/2003SE |
| K021498 | Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelJJT · Traditional | Bio-Rad | 05/24/2002SE |
| K012656 | Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648JJT · Traditional | Bio-Rad | 09/06/2001SE |
| K993715 | Qualitrol Cardiac Marker Control, Levels, 1,2 and 3JJT · Traditional | Seracare Technology | 11/16/1999SE |
| K992430 | Cardioimmune Cardiac Marker Control Levels 1,2, and 3JJT · Traditional | Medical Analysis Systems, Inc. | 08/30/1999SE |
| K984437 | Quantex Aso-Crp-Rp Control IIJJT · Traditional | Instrumentation Laboratory CO | 02/02/1999SE |
| K984277 | Cardioimmune Cardiac Marker Control Levels 1,2, and 3JJT · Traditional | Medical Analysis Systems, Inc. | 12/09/1998SE |
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| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | 10/30/2006SE |
| K062751 | Modification to Quantimetrix Cardiasure Cardiac MarkerJJT · Special | 10/03/2006SE |
| K060417 | Modification to Quantimetrix Urine Drugs of Abuse ControlDIF · Special | 03/21/2006SE |
| K032791 | Glycohemosure HBA1C ControlGGM · Traditional | 10/30/2003SE |
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Questions and answers
When was Cardiasure Cardiac Markers Control cleared by the FDA?
Cardiasure Cardiac Markers Control (K993723) received a 510(k) decision of Substantially Equivalent on November 23, 1999, 20 days after the submission was received.
What is the product code of K993723?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.