Triage B-Type Natriuretic Peptide (BNP) Controls
FDA 510(k) K000230 · Biosite Incorporated
510(k) numberK000230
Submission
- Device name
- Triage B-Type Natriuretic Peptide (BNP) Controls
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- January 27, 2000
- Decision date
- February 29, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Triage B-Type Natriuretic Peptide (BNP) Controls cleared by the FDA?
Triage B-Type Natriuretic Peptide (BNP) Controls (K000230) received a 510(k) decision of Substantially Equivalent on February 29, 2000, 33 days after the submission was received.
What is the product code of K000230?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.