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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 K923158
Device Name LUMICO ANALYZER SA-300
Applicant
Maruzen Petrochemical Co., Ltd.
25-10 Hatchobori 2 Chome
Chuo-Ku, Tokyo 104
Japan,  JP
Applicant Contact KINYA FUJII
Correspondent
Maruzen Petrochemical Co., Ltd.
25-10 Hatchobori 2 Chome
Chuo-Ku, Tokyo 104
Japan,  JP
Correspondent Contact KINYA FUJII
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/29/1992
Decision Date 11/17/1992
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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