Biocheck CARDIAC-1 CRP Rapid Test, Model BC-804114
FDA 510(k) K040030 · Biocheck, Inc.
510(k) numberK040030
Submission
- Device name
- Biocheck CARDIAC-1 CRP Rapid Test, Model BC-804114
- Applicant
- Biocheck, Inc.
Northridge, CA, US - Received
- January 7, 2004
- Decision date
- June 16, 2004
- 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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| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | Abaxis, Inc. | 01/15/2010SE |
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Questions and answers
When was Biocheck CARDIAC-1 CRP Rapid Test, Model BC-804114 cleared by the FDA?
Biocheck CARDIAC-1 CRP Rapid Test, Model BC-804114 (K040030) received a 510(k) decision of Substantially Equivalent on June 16, 2004, 161 days after the submission was received.
What is the product code of K040030?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.