Liquichek Cardiac Markers Control LT
FDA 510(k) K980556 · Bio-Rad
510(k) numberK980556
Submission
- Device name
- Liquichek Cardiac Markers Control LT
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- February 13, 1998
- Decision date
- February 25, 1998
- 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
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| K030102 | Advia Centaur and ACS:180 Liquid Cardiac Markers 1, 2, 3JJT · Abbreviated | Bayer Healthcare, LLC | 01/24/2003SE |
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| K993723 | Cardiasure Cardiac Markers ControlJJT · Traditional | Quantimetrix Corp. | 11/23/1999SE |
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| 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 |
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Questions and answers
When was Liquichek Cardiac Markers Control LT cleared by the FDA?
Liquichek Cardiac Markers Control LT (K980556) received a 510(k) decision of Substantially Equivalent on February 25, 1998, 12 days after the submission was received.
What is the product code of K980556?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.