Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test
FDA 510(k) K033606 · Axis-Shield Diagnostics, Ltd.
510(k) numberK033606
Submission
- Device name
- Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test
- Applicant
- Axis-Shield Diagnostics, Ltd.
Dundee, Scotland, GB - Received
- November 17, 2003
- Decision date
- January 30, 2004
- 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 Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test cleared by the FDA?
Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test (K033606) received a 510(k) decision of Substantially Equivalent on January 30, 2004, 74 days after the submission was received.
What is the product code of K033606?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.