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510(k) K211199

ST AIA-PACK BNP Assay by Tosoh Bioscience, Inc. — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2021
Date Received
April 22, 2021
Clearance Type
Special
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

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  • K092649 — ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109 (February 4, 2010)
  • K082645 — DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRI (September 22, 2008)