Advia Centaur and ACS:180 Liquid Cardiac Markers 1, 2, 3
FDA 510(k) K030102 · Bayer Healthcare, LLC
510(k) numberK030102
Submission
- Device name
- Advia Centaur and ACS:180 Liquid Cardiac Markers 1, 2, 3
- Applicant
- Bayer Healthcare, LLC
Tarrytown, NY, US - Received
- January 10, 2003
- Decision date
- January 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
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| 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 |
| 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 |
| K993723 | Cardiasure Cardiac Markers ControlJJT · Traditional | Quantimetrix Corp. | 11/23/1999SE |
| 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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Questions and answers
When was Advia Centaur and ACS:180 Liquid Cardiac Markers 1, 2, 3 cleared by the FDA?
Advia Centaur and ACS:180 Liquid Cardiac Markers 1, 2, 3 (K030102) received a 510(k) decision of Substantially Equivalent on January 24, 2003, 14 days after the submission was received.
What is the product code of K030102?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.