Paragon Cze 2000 Clinical Capillary Electrophoresis System
FDA 510(k) K953077 · Beckman Instruments, Inc.
510(k) numberK953077
Submission
- Device name
- Paragon Cze 2000 Clinical Capillary Electrophoresis System
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- June 30, 1995
- Decision date
- January 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDF – Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1795
- Specialty
- Clinical Chemistry
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Questions and answers
When was Paragon Cze 2000 Clinical Capillary Electrophoresis System cleared by the FDA?
Paragon Cze 2000 Clinical Capillary Electrophoresis System (K953077) received a 510(k) decision of Substantially Equivalent on January 5, 1996, 189 days after the submission was received.
What is the product code of K953077?
The FDA product code is CDF – Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin, a Class I (low risk) device regulated under 21 CFR 862.1795.