FDA 510(k) Application Details - K941807

Device Classification Name Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride

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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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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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