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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 K894503
Device Name GEMTAB SYSTEM
Applicant
Pharmacia Eni Diagnostics, Inc.
8310 Guilford Rd.
Suite E
Columbia,  MD  21046
Applicant Contact BRANDT
Correspondent
Pharmacia Eni Diagnostics, Inc.
8310 Guilford Rd.
Suite E
Columbia,  MD  21046
Correspondent Contact BRANDT
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/19/1989
Decision Date 09/05/1989
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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