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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 K883302
Device Name EMAX PRECISION MICROPLATE READER
Applicant
Molecular Devices Corp.
3180 Porter Dr.
Palo Alto,  CA  94304
Applicant Contact SHEILA W PICKERING
Correspondent
Molecular Devices Corp.
3180 Porter Dr.
Palo Alto,  CA  94304
Correspondent Contact SHEILA W PICKERING
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received08/04/1988
Decision Date 09/13/1988
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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