Dimension Vista PBNP Flex Reagent Cartridge and Calibrator
FDA 510(k) K061795 · Dade Behring, Inc.
510(k) numberK061795
Submission
- Device name
- Dimension Vista PBNP Flex Reagent Cartridge and Calibrator
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- June 23, 2006
- Decision date
- September 11, 2006
- 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 Dimension Vista PBNP Flex Reagent Cartridge and Calibrator cleared by the FDA?
Dimension Vista PBNP Flex Reagent Cartridge and Calibrator (K061795) received a 510(k) decision of Substantially Equivalent on September 11, 2006, 80 days after the submission was received.
What is the product code of K061795?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.