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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K922976
Device Name LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT
Applicant
EG&G BERTHOLD ANALYTICAL INSTRUMENTS, INC.
472 AMHERST ST.
NASHUA,  NH  03063
Applicant Contact MICHAEL S CIANCI
Correspondent
EG&G BERTHOLD ANALYTICAL INSTRUMENTS, INC.
472 AMHERST ST.
NASHUA,  NH  03063
Correspondent Contact MICHAEL S CIANCI
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received05/29/1992
Decision Date 11/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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