Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119
FDA 510(k) K003851 · Biocheck, Inc.
510(k) numberK003851
Submission
- Device name
- Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119
- Applicant
- Biocheck, Inc.
Northridge, CA, US - Received
- December 12, 2000
- Decision date
- July 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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Questions and answers
When was Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119 cleared by the FDA?
Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119 (K003851) received a 510(k) decision of Substantially Equivalent on July 20, 2001, 220 days after the submission was received.
What is the product code of K003851?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.