Abbott Alcyon(Tm) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer
FDA 510(k) K974779 · Abbott Laboratories
510(k) numberK974779
Submission
- Device name
- Abbott Alcyon(Tm) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- December 22, 1997
- Decision date
- February 13, 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 Alcyon(Tm) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer cleared by the FDA?
Abbott Alcyon(Tm) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer (K974779) received a 510(k) decision of Substantially Equivalent on February 13, 1998, 53 days after the submission was received.
What is the product code of K974779?
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.