Synchron CX5CE Clinical Analyzer
FDA 510(k) K926060 · Beckman Instruments, Inc.
510(k) numberK926060
Submission
- Device name
- Synchron CX5CE Clinical Analyzer
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- December 1, 1992
- Decision date
- February 12, 1993
- 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 Synchron CX5CE Clinical Analyzer cleared by the FDA?
Synchron CX5CE Clinical Analyzer (K926060) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 73 days after the submission was received.
What is the product code of K926060?
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.