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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
Other 510(k) Applications for this Contact
Regulation Number
866.4520
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Classification Product Code
JZT
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More FDA Info for this Product Code
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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