FDA 510(k) Application Details - K962499

Device Classification Name Fluorometer

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510(K) Number K962499
Device Name Fluorometer
Applicant BARTELS, INC.
2005 N.W. SAMMAMISH RD., #107
ISSAQUAH, WA 98027 US
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Contact REBECCA D FULLER
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Regulation Number 866.4520

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Classification Product Code JZT
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Date Received 06/26/1996
Decision Date 09/05/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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