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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K002974
Device Name EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL
Applicant
Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95161
Applicant Contact PAUL L ROGERS
Correspondent
Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95161
Correspondent Contact PAUL L ROGERS
Regulation Number862.3030
Classification Product Code
LDP  
Subsequent Product Code
DKB  
Date Received08/17/2000
Decision Date 10/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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