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FDA 510(k) Application Details - K941807
Device Classification Name
Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
More FDA Info for this Device
510(K) Number
K941807
Device Name
Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
Applicant
INTERSECT SYSTEMS, INC.
1152 3RD AVE., SUITE D/E
P.O. BOX 2219
LONGVIEW, WA US
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Contact
TARAS TATARKO
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Regulation Number
862.1170
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Classification Product Code
CHG
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More FDA Info for this Product Code
Date Received
04/12/1994
Decision Date
09/14/1994
Decision
SE - Substantially Equivalent
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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