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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K880705
Device Name THERAPEUTIC DRUG 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 Number862.3200
Classification Product Code
DKB  
Date Received02/22/1988
Decision Date 05/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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