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FDA 510(k) Application Details - K961209
Device Classification Name
Analyzer, Chemistry, Micro, For Clinical Use
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510(K) Number
K961209
Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Applicant
SEAC S.R.L.
45 PONTIAL RO
NEWTON, MA 02168 US
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Contact
JOSEPH RESS
Other 510(k) Applications for this Contact
Regulation Number
862.2170
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Classification Product Code
JJF
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More FDA Info for this Product Code
Date Received
03/28/1996
Decision Date
12/24/1996
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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