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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K043546
Device Name DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
Applicant
DADE BEHRING, INC.
500 GBC DR., M/S 514
P.O. BOX 6101
NEWARK,  DE  19714
Applicant Contact STANLEY GORAK
Correspondent
DADE BEHRING, INC.
500 GBC DR., M/S 514
P.O. BOX 6101
NEWARK,  DE  19714
Correspondent Contact STANLEY GORAK
Regulation Number862.1705
Classification Product Code
CDT  
Subsequent Product Codes
CDQ   CEC   CEK   CEM   CEO  
CFJ   CFQ   CFR   CGS   CGX   CGZ  
CHH   CHI   CIC   CIG   CIT   CJE  
CJW   CKA   CKE   CZW   DBI   DCF  
DCN   DDG   DDR   DHA   DIH   DIO  
DIP   DIS   DJG   DJR   DKJ   DKZ  
DLZ   DMJ   JFJ   JFL   JGJ   JHC  
JHM   JHT   JHY   JIF   JIH   JJE  
JLW   JMG   JMO   JQB   JXM   KHP  
KHQ   KHS   KLB   KLI   KLR   KLS  
KLT   KXT   LAN   LAR   LCD   LCM  
LCP   LDJ   LDP   LEG   LEH   LFM  
MKW   MMI   MRR   NBC  
Date Received12/23/2004
Decision Date 01/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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