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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 K942836
Device Name FINGERPRINT-DOA
Applicant
Fingerprint Bioteck, Inc.
2930 Prosperity Ave.
Fairfax,  VA  22031
Applicant Contact SUNG C LEE
Correspondent
Fingerprint Bioteck, Inc.
2930 Prosperity Ave.
Fairfax,  VA  22031
Correspondent Contact SUNG C LEE
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   LCM   LDJ  
Date Received06/15/1994
Decision Date 05/01/1995
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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