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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Methamphetamine
510(k) Number K000979
Device Name REDI-SCREEN
Applicant
Redwood Biotech, Inc.
1206 Sesame Dr.
Sunnyvale,  CA  94087
Applicant Contact JANIS FREESTONE
Correspondent
Redwood Biotech, Inc.
1206 Sesame Dr.
Sunnyvale,  CA  94087
Correspondent Contact JANIS FREESTONE
Regulation Number862.3610
Classification Product Code
LAF  
Subsequent Product Codes
DIO   DJG   LCM   LDJ  
Date Received03/27/2000
Decision Date 04/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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