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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 K933088
Device Name PLATO 3000
Applicant
Rosys, Inc.
1309 Veale Rd.
Suite 21
Wilmington,  DE  19810
Applicant Contact LEE CARTER
Correspondent
Rosys, Inc.
1309 Veale Rd.
Suite 21
Wilmington,  DE  19810
Correspondent Contact LEE CARTER
Regulation Number862.2750
Classification Product Code
JQW  
Date Received06/23/1993
Decision Date 02/25/1994
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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