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FDA 510(k) Application Details - K014225
Device Classification Name
Test, Urea (Breath Or Blood)
More FDA Info for this Device
510(K) Number
K014225
Device Name
Test, Urea (Breath Or Blood)
Applicant
MERETEK DIAGNOSTICS, INC.
618 GRASSMERE PARK DRIVE,
SUITE 20
NASHVILLE, TN 37211 US
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Contact
DENISE E SPELLMAN
Other 510(k) Applications for this Contact
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
12/26/2001
Decision Date
01/17/2002
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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