Selecta 20/60 Chemistry Analyzer
FDA 510(k) K942922 · Select Medical Systems, Inc.
510(k) numberK942922
Submission
- Device name
- Selecta 20/60 Chemistry Analyzer
- Applicant
- Select Medical Systems, Inc.
Birmingham, AL, US - Received
- June 21, 1994
- Decision date
- July 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Selecta 20/60 Chemistry Analyzer cleared by the FDA?
Selecta 20/60 Chemistry Analyzer (K942922) received a 510(k) decision of Substantially Equivalent on July 19, 1995, 393 days after the submission was received.
What is the product code of K942922?
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.