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510(k) K063662

RAMP NT-PROBNP ASSAY by Response Biomedical Corp. — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2008
Date Received
December 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
Submission Type

Other clearances by Response Biomedical Corp.

  • K093116 — MODIFICATION TO: RAMP INFLUENZA A/B ASSAY (October 21, 2009)
  • K091235 — RAMP RSV ASSAY (July 24, 2009)
  • K071591 — RAMP INFLUENZA A/B ASSAY (April 16, 2008)
  • K033747 — RAMP CK-MB ASSAY (May 17, 2004)
  • K033745 — RAMP TROPONIN I ASSAY (May 17, 2004)
  • K012040 — RAMP MYOGLOBIN ASSAY (December 18, 2001)

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  • K223637 — Elecsys proBNP II, Elecsys proBNP II STAT (July 21, 2023)
  • K210546 — Elecsys proBNP II, Elecsys proBNP II STAT (March 31, 2022)
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  • K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (October 4, 2021)
  • K192380 — ST AIA-PACK BNP (August 24, 2020)
  • K092649 — ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109 (February 4, 2010)