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510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: TEST, NATRIURETIC PEPTIDE
Regulation Number: 862.1117
[See Other Products with this regulation number]
510(k) Number: K032525
Device Name: BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Applicant: BAYER HEALTHCARE, LLC
511 BENEDICT AVE.

TARRYTOWN, NY 10591
Contact: ANDRES HOLLE
Product Code: NBC
[See Other Manufacturers that make this Product]
Date Received: 08-15-2003
Decision Date: 09-09-2003
Decision: CS
Advisory Committee: CH
Statement/Summary/Purged Status: Summary
Type: Special
Review by Third Party: N
Expedited Review: N
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