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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K952025
Device Name ROBOCAP
Applicant
Pharmacia, Inc.
7001 Post Rd.
Dublin,  OH  43017
Applicant Contact JEAN FRYDMAN
Correspondent
Pharmacia, Inc.
7001 Post Rd.
Dublin,  OH  43017
Correspondent Contact JEAN FRYDMAN
Regulation Number862.2750
Classification Product Code
JQW  
Date Received05/01/1995
Decision Date 07/26/1995
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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