FDA 510(k) Application Details - K971524

Device Classification Name Biuret (Colorimetric), Total Protein

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510(K) Number K971524
Device Name Biuret (Colorimetric), Total Protein
Applicant CAROLINA LIQUID CHEMISTRIES CORP.
451 WEST LAMBERT RD.,
SUITE 207
BREA, CA 92821 US
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Contact CYNTHIA SHUGART
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Regulation Number 862.1635

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Classification Product Code CEK
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Date Received 04/28/1997
Decision Date 05/16/1997
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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