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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K972333
Device Name AMMONIA/IRON STANDARD KIT
Applicant
VERICHEM LABORATORIES, INC.
90 NARRAGANSETT AVE.
PROVIDENCE,  RI  02907
Applicant Contact ANTHONY J DIMONTE
Correspondent
VERICHEM LABORATORIES, INC.
90 NARRAGANSETT AVE.
PROVIDENCE,  RI  02907
Correspondent Contact ANTHONY J DIMONTE
Regulation Number862.1150
Classification Product Code
JIX  
Date Received06/23/1997
Decision Date 07/23/1997
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
Recalls CDRH Recalls
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