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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K882362
Device Name STAT FIX MICROWAVE IRRADIATION MEDIUM
Applicant
Stat Path
P.O. Box 6
Riderwood,  MD  21139
Applicant Contact R BOSTWICK
Correspondent
Stat Path
P.O. Box 6
Riderwood,  MD  21139
Correspondent Contact R BOSTWICK
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received06/07/1988
Decision Date 06/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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