Synchron CX4CE/CX5CE/CX7 Clinical Systems Software Update Version 4.0
FDA 510(k) K951189 · Beckman Instruments, Inc.
510(k) numberK951189
Submission
- Device name
- Synchron CX4CE/CX5CE/CX7 Clinical Systems Software Update Version 4.0
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- March 16, 1995
- Decision date
- June 13, 1995
- 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 CX4CE/CX5CE/CX7 Clinical Systems Software Update Version 4.0 cleared by the FDA?
Synchron CX4CE/CX5CE/CX7 Clinical Systems Software Update Version 4.0 (K951189) received a 510(k) decision of Substantially Equivalent on June 13, 1995, 89 days after the submission was received.
What is the product code of K951189?
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.