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FDA 510(k) Application Details - K990971
Device Classification Name
Electrolyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K990971
Device Name
Electrolyte Controls (Assayed And Unassayed)
Applicant
MEDICA CORP.
14 DEANGELO DR.
BEDFORD, MA 01730 US
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Contact
Photios Makris
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
JJR
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More FDA Info for this Product Code
Date Received
03/23/1999
Decision Date
04/27/1999
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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