Crpex-Hs C-Reactive Protein Lit Assay, Catalog No. 1010
FDA 510(k) K020603 · Good Biotech Corp.
510(k) numberK020603
Submission
- Device name
- Crpex-Hs C-Reactive Protein Lit Assay, Catalog No. 1010
- Applicant
- Good Biotech Corp.
Taichung, TW - Received
- February 25, 2002
- Decision date
- June 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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Questions and answers
When was Crpex-Hs C-Reactive Protein Lit Assay, Catalog No. 1010 cleared by the FDA?
Crpex-Hs C-Reactive Protein Lit Assay, Catalog No. 1010 (K020603) received a 510(k) decision of Substantially Equivalent on June 13, 2002, 108 days after the submission was received.
What is the product code of K020603?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.