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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 K102779
Device Name EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C
Applicant
Siemens Healthcare Diagnostics Inc.
P.O. BOX 6101
MAILBOX 514
NEWARK,  DE  19714
Applicant Contact JANET M FOSE
Correspondent
Siemens Healthcare Diagnostics Inc.
P.O. BOX 6101
MAILBOX 514
NEWARK,  DE  19714
Correspondent Contact JANET M FOSE
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIF   DKB  
Date Received09/24/2010
Decision Date 03/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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