Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge, Model RF623
FDA 510(k) K082645 · Siemens Healthcare Diagnostics
510(k) numberK082645
Submission
- Device name
- Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge, Model RF623
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- September 11, 2008
- Decision date
- September 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge, Model RF623 cleared by the FDA?
Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge, Model RF623 (K082645) received a 510(k) decision of Substantially Equivalent on September 22, 2008, 11 days after the submission was received.
What is the product code of K082645?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.