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FDA 510(k) Application Details - K971761
Device Classification Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
More FDA Info for this Device
510(K) Number
K971761
Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
100 CASCADE DR.
ALLENTOWN, PA 18103-9562 US
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Contact
JAMES SAFRANKO
Other 510(k) Applications for this Contact
Regulation Number
862.2160
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Classification Product Code
JJE
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More FDA Info for this Product Code
Date Received
05/12/1997
Decision Date
07/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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