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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, Opiates
510(k) Number K020716
Device Name RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
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 Number862.3650
Classification Product Code
DJG  
Date Received03/05/2002
Decision Date 05/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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