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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 K891869
Device Name CLS 962 MICROPLATE PHOTOMETER
Applicant
Cambridge Life Sciences Plc.
Science Park Milton Rd.
Cambridge, England,  GB CB4 4GN
Applicant Contact R. A NEWSTEAD
Correspondent
Cambridge Life Sciences Plc.
Science Park Milton Rd.
Cambridge, England,  GB CB4 4GN
Correspondent Contact R. A NEWSTEAD
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/27/1989
Decision Date 05/09/1989
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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