FDA 510(k) Application Details - K954977

Device Classification Name Refractometer For Clinical Use

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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
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Regulation Number 862.2800

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Classification Product Code JRE
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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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