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FDA 510(k) Application Details - K971458
Device Classification Name
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
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510(K) Number
K971458
Device Name
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant
DIAGNOSTIC SPECIALTIES
4 LEONARD ST.
METUCHEN, NJ 08840-4338 US
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Contact
RINALDO PAGNUCCO
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Regulation Number
862.1645
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Classification Product Code
JIQ
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More FDA Info for this Product Code
Date Received
04/22/1997
Decision Date
09/02/1997
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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