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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, Amphetamine
510(k) Number K003809
Device Name RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
Applicant
Rapid Diagnostics, Inc.
1429 Rollins Rd.
Burlingame,  CA  94010
Applicant Contact CHARLES C.F. YU
Correspondent
Rapid Diagnostics, Inc.
1429 Rollins Rd.
Burlingame,  CA  94010
Correspondent Contact CHARLES C.F. YU
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJC   DJG   JXM   LDJ  
Date Received12/08/2000
Decision Date 04/20/2001
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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