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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K022603
Device Name IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact EDWARD M LEVINE
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact EDWARD M LEVINE
Regulation Number862.1545
Classification Product Code
CEW  
Subsequent Product Codes
CDD   CDP   CDZ   CEC   CEE  
CEP   CFL   CFP   CFT   CGI   CGJ  
CGN   CGR   CGT   CHP   CKG   DCN  
DDR   DFJ   DGO   DHA   DHB   DHX  
DIO   DIP   DKZ   JFH   JHR   JHX  
JJE   JKC   JKD   JLS   JMF   JMG  
JMM   JZG   JZO   KLI   KLS   KLT  
KXT   LAF   LDJ   LEG   LFM   LFX  
LFZ   LGC   LGD   LOJ   LPS   LTJ  
LTK   LYR   MMI   MOI   MSW  
Date Received08/06/2002
Decision Date 08/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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