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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K942551
Device Name THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
Applicant
Medi-Tech, Inc.
6020 Nicolle St.
Ventura,  CA  93003
Applicant Contact SHING KWAN
Correspondent
Medi-Tech, Inc.
6020 Nicolle St.
Ventura,  CA  93003
Correspondent Contact SHING KWAN
Regulation Number862.3280
Classification Product Code
DIF  
Date Received05/31/1994
Decision Date 10/06/1994
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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