Bio-Rad Total Protein Test Kit
FDA 510(k) K913315 · Bio-Rad
510(k) numberK913315
Submission
- Device name
- Bio-Rad Total Protein Test Kit
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- July 25, 1991
- Decision date
- January 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Bio-Rad Total Protein Test Kit cleared by the FDA?
Bio-Rad Total Protein Test Kit (K913315) received a 510(k) decision of Substantially Equivalent on January 2, 1992, 161 days after the submission was received.
What is the product code of K913315?
The FDA product code is CEF – Electrophoretic, Protein Fractionation, a Class I (low risk) device regulated under 21 CFR 862.1630.