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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Slide Stainer, Automated
510(k) Number K821830
Device Name MI DAS 1000 AUTOMATIC SLIDE STAINER
Applicant
INNOVATIVE MEDICAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INNOVATIVE MEDICAL SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.3800
Classification Product Code
KPA  
Date Received06/22/1982
Decision Date 07/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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