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FDA 510(k) Application Details - K954977
Device Classification Name
Refractometer For Clinical Use
More FDA Info for this Device
510(K) Number
K954977
Device Name
Refractometer For Clinical Use
Applicant
TECO DIAGNOSTICS
911 VIA RODEO
PLACENTIA, CA 92670 US
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Contact
K.C. CHEN
Other 510(k) Applications for this Contact
Regulation Number
862.2800
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Classification Product Code
JRE
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More FDA Info for this Product Code
Date Received
10/16/1995
Decision Date
03/11/1996
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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