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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 K011465
Device Name SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Applicant Contact MARY B TANG
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Correspondent Contact MARY B TANG
Regulation Number862.3030
Classification Product Code
LDP  
Subsequent Product Codes
CDQ   CDT   CEK   CEM   CFJ  
CFR   CGA   CGS   CGX   CGZ   CHH  
CHI   CHW   CIG   CIT   CJE   CJW  
CJY   CKA   CZP   DCF   DCK   DDG  
DDT   DEW   DFT   DHR   DIO   DIP  
DIS   DJG   DJR   DKJ   DKZ   DLZ  
DMT   GTQ   JFJ   JFL   JFM   JFP  
JGG   JGS   JHW   JJE   JMO   JOB  
JXM   JXN   JZJ   KHQ   KLI   KLS  
KLT   KXS   KXT   LCD   LCM   LCP  
LCR   LDJ   LEG  
Date Received05/14/2001
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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