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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K901113
Device Name MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
Applicant
Verichem Laboratories, Inc.
3226 Pawtucket Ave.
Suite #1
East Providence,  RI  02915
Applicant Contact ANTHONY J DIMONTE
Correspondent
Verichem Laboratories, Inc.
3226 Pawtucket Ave.
Suite #1
East Providence,  RI  02915
Correspondent Contact ANTHONY J DIMONTE
Regulation Number862.1150
Classification Product Code
JIS  
Date Received03/07/1990
Decision Date 03/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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