Abbott Axsym System
FDA 510(k) K974651 · Abbott Laboratories
510(k) numberK974651
Submission
- Device name
- Abbott Axsym System
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- December 8, 1997
- Decision date
- February 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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Questions and answers
When was Abbott Axsym System cleared by the FDA?
Abbott Axsym System (K974651) received a 510(k) decision of Substantially Equivalent on February 12, 1998, 66 days after the submission was received.
What is the product code of K974651?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.