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FDA 510(k) Application Details - K961588
Device Classification Name
Photometric Method, Iron (Non-Heme)
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510(K) Number
K961588
Device Name
Photometric Method, Iron (Non-Heme)
Applicant
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK, MI 48146 US
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Contact
WILLIAM F WALTERS
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Regulation Number
862.1410
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Classification Product Code
JIY
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More FDA Info for this Product Code
Date Received
04/24/1996
Decision Date
11/18/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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