Paragon Serum Protein Electrophoresis
FDA 510(k) K802592 · Beckman Instruments, Inc.
510(k) numberK802592
Submission
- Device name
- Paragon Serum Protein Electrophoresis
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- October 21, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEF – Electrophoretic, Protein Fractionation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1630
- Specialty
- Clinical Chemistry
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Questions and answers
When was Paragon Serum Protein Electrophoresis cleared by the FDA?
Paragon Serum Protein Electrophoresis (K802592) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 22 days after the submission was received.
What is the product code of K802592?
The FDA product code is CEF – Electrophoretic, Protein Fractionation, a Class I (low risk) device regulated under 21 CFR 862.1630.