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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 K955155
Device Name DOCUMENT TDM ULTRA UNASSAYED CONTROL
Applicant
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Applicant Contact CHRISTINE V BEACH
Correspondent
Casco Standards
P.O Box 970
Yarmouth,  ME  04096
Correspondent Contact CHRISTINE V BEACH
Regulation Number862.3280
Classification Product Code
DIF  
Date Received11/13/1995
Decision Date 12/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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