Cardiac Markers Control - Level 1, Level 2, Level 3, Tri-Level
FDA 510(k) K972976 · More Diagnostics
510(k) numberK972976
Submission
- Device name
- Cardiac Markers Control - Level 1, Level 2, Level 3, Tri-Level
- Applicant
- More Diagnostics
Los Osos, CA, US - Received
- August 11, 1997
- Decision date
- August 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Cardiac Markers Control - Level 1, Level 2, Level 3, Tri-Level cleared by the FDA?
Cardiac Markers Control - Level 1, Level 2, Level 3, Tri-Level (K972976) received a 510(k) decision of Substantially Equivalent on August 29, 1997, 18 days after the submission was received.
What is the product code of K972976?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.