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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 K943454
Device Name PLATO 3300/1300
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 Number862.2300
Classification Product Code
JJQ  
Date Received07/18/1994
Decision Date 01/09/1995
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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