FDA 510(k), K021317, TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

FDA 510(k), K021317, TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

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510(K) Number: K021317
Device Name: TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
Manufacturer: BIOSITE INCORPORATED
Device Classification Name: test, natriuretic peptide
Regulation Number: 862.1117
Classification Product Code: NBC
Date Received: 04/25/2002
Decision Date: 07/01/2002
Regulation Medical Specialty: Clinical Chemistry
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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