Triage Cardioprofiler and Profiler S.O.B. Panels
FDA 510(k) K080269 · Biosite Incorporated
510(k) numberK080269
Submission
- Device name
- Triage Cardioprofiler and Profiler S.O.B. Panels
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- February 1, 2008
- Decision date
- June 6, 2008
- 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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| K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200NBC · Traditional | 01/23/2006SE |
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Questions and answers
When was Triage Cardioprofiler and Profiler S.O.B. Panels cleared by the FDA?
Triage Cardioprofiler and Profiler S.O.B. Panels (K080269) received a 510(k) decision of Substantially Equivalent on June 6, 2008, 126 days after the submission was received.
What is the product code of K080269?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.