Triage Protein C Test
FDA 510(k) K062530 · Biosite Incorporated
510(k) numberK062530
Submission
- Device name
- Triage Protein C Test
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- August 29, 2006
- Decision date
- January 29, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was Triage Protein C Test cleared by the FDA?
Triage Protein C Test (K062530) received a 510(k) decision of Substantially Equivalent on January 29, 2007, 153 days after the submission was received.
What is the product code of K062530?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.