Elecsys Probnp Immunoassay
FDA 510(k) K051382 · Roche Diagnostics Corp.
510(k) numberK051382
Submission
- Device name
- Elecsys Probnp Immunoassay
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- May 27, 2005
- Decision date
- December 5, 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 Elecsys Probnp Immunoassay cleared by the FDA?
Elecsys Probnp Immunoassay (K051382) received a 510(k) decision of Substantially Equivalent on December 5, 2005, 192 days after the submission was received.
What is the product code of K051382?
The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.