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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K970227
Device Name IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
Applicant
DPC CIRRUS
111 CANFIELD AVE., B15
RANDOLPH,  NJ  07869 -1114
Applicant Contact ROBERT M DI TULLIO
Correspondent
DPC CIRRUS
111 CANFIELD AVE., B15
RANDOLPH,  NJ  07869 -1114
Correspondent Contact ROBERT M DI TULLIO
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CGJ   DHB   JHR   JLW   KLS  
Date Received01/17/1997
Decision Date 04/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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