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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 K991598
Device Name COBAS INTEGRA ACETAMINOPHEN
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact LISA GERARD
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact LISA GERARD
Regulation Number862.3030
Classification Product Code
LDP  
Date Received05/10/1999
Decision Date 07/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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