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FDA 510(k) Application Details - K000316
Device Classification Name
Test, Urea (Breath Or Blood)
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510(K) Number
K000316
Device Name
Test, Urea (Breath Or Blood)
Applicant
MERETEK
618 GRASSMERE PARK DR.
SUITE 20
NASHVILLE, TN 37211 US
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Contact
KERRY BUSH
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Regulation Number
866.3110
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Classification Product Code
MSQ
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More FDA Info for this Product Code
Date Received
02/01/2000
Decision Date
02/24/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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