Stratus CS Acute Care Nt-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent
FDA 510(k) K043476 · Dade Behring, Inc.
510(k) numberK043476
Submission
- Device name
- Stratus CS Acute Care Nt-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- December 16, 2004
- Decision date
- February 15, 2005
- 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 Stratus CS Acute Care Nt-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent cleared by the FDA?
Stratus CS Acute Care Nt-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent (K043476) received a 510(k) decision of Substantially Equivalent on February 15, 2005, 61 days after the submission was received.
What is the product code of K043476?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.