Triage BNP Test, Model 98000XR
FDA 510(k) K051787 · Biosite Incorporated
510(k) numberK051787
Submission
- Device name
- Triage BNP Test, Model 98000XR
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- July 1, 2005
- Decision date
- September 22, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBC – Test, Natriuretic Peptide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1117
- Specialty
- Clinical Chemistry
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Questions and answers
When was Triage BNP Test, Model 98000XR cleared by the FDA?
Triage BNP Test, Model 98000XR (K051787) received a 510(k) decision of Substantially Equivalent on September 22, 2005, 83 days after the submission was received.
What is the product code of K051787?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.