Modification to Dimension Nt-Probnp Flex Reagent Cartridge Method
FDA 510(k) K042347 · Dade Behring, Inc.
510(k) numberK042347
Submission
- Device name
- Modification to Dimension Nt-Probnp Flex Reagent Cartridge Method
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- August 30, 2004
- Decision date
- November 19, 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 Modification to Dimension Nt-Probnp Flex Reagent Cartridge Method cleared by the FDA?
Modification to Dimension Nt-Probnp Flex Reagent Cartridge Method (K042347) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 81 days after the submission was received.
What is the product code of K042347?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.