Abbott Prism Analyzer
FDA 510(k) K940289 · Abbott Mfg., Inc.
510(k) numberK940289
Submission
- Device name
- Abbott Prism Analyzer
- Applicant
- Abbott Mfg., Inc.
Irving, TX, US - Received
- March 2, 1994
- Decision date
- July 18, 1994
- 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 Prism Analyzer cleared by the FDA?
Abbott Prism Analyzer (K940289) received a 510(k) decision of Substantially Equivalent on July 18, 1994, 138 days after the submission was received.
What is the product code of K940289?
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.