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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Urea (Breath Or Blood)
510(k) Number K014225
Device Name BREATHTEK - UBIT UBT FOR H. PYLORI
Applicant
Meretek Diagnostics, Inc.
618 Grassmere Park Dr.
Suite 20
Nashville,  TN  37211
Applicant Contact DENISE E SPELLMAN
Correspondent
Meretek Diagnostics, Inc.
618 Grassmere Park Dr.
Suite 20
Nashville,  TN  37211
Correspondent Contact DENISE E SPELLMAN
Regulation Number866.3110
Classification Product Code
MSQ  
Date Received12/26/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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