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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K972960
Device Name HEALTH CHECK URI-TEST PROTEIN IN URINE
Applicant
Tcpi, Inc.
15 Oak St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Tcpi, Inc.
15 Oak St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number862.1645
Classification Product Code
JIR  
Date Received08/11/1997
Decision Date 10/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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