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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alcohol Control Materials
510(k) Number K912826
Device Name WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
Applicant
Cala Diagnostics
P.O. Box 6714
Los Osos,  CA  93412
Applicant Contact JAMES F GODFREY
Correspondent
Cala Diagnostics
P.O. Box 6714
Los Osos,  CA  93412
Correspondent Contact JAMES F GODFREY
Regulation Number862.3280
Classification Product Code
DKC  
Date Received06/26/1991
Decision Date 07/26/1991
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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