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FDA 510(k) Application Details - K990978
Device Classification Name
Bromcresol Purple Dye-Binding, Albumin
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510(K) Number
K990978
Device Name
Bromcresol Purple Dye-Binding, Albumin
Applicant
A.P. TOTAL CARE, INC.
70 HAWLEY AVE,
PO BOX 6216
BRIDGEPORT, CT US
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Contact
LUIS P LEON
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Regulation Number
862.1035
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Classification Product Code
CJW
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More FDA Info for this Product Code
Date Received
03/23/1999
Decision Date
05/25/1999
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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