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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
Recalls CDRH Recalls
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