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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 K921005
Device Name AUTOLOADER
Applicant
INNOVATIVE MEDICAL SYSTEMS, INC.
55 STEAM WHISTLE DR.
IVYLAND,  PA  18974
Applicant Contact RICHARD CRYMES
Correspondent
INNOVATIVE MEDICAL SYSTEMS, INC.
55 STEAM WHISTLE DR.
IVYLAND,  PA  18974
Correspondent Contact RICHARD CRYMES
Regulation Number862.2750
Classification Product Code
JQW  
Date Received03/03/1992
Decision Date 04/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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