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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 K913664
Device Name ROSYS MODELS 100 AND 200
Applicant
Packard Instrument Co., Inc.
2200 Warrenville Rd.
Downers Grove,  IL  60515
Applicant Contact DOROTHY MRKVICKA
Correspondent
Packard Instrument Co., Inc.
2200 Warrenville Rd.
Downers Grove,  IL  60515
Correspondent Contact DOROTHY MRKVICKA
Regulation Number862.2750
Classification Product Code
JQW  
Date Received08/16/1991
Decision Date 08/30/1991
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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