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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 K880745
Device Name LX-100 SLIDE STAINER
Applicant
Innovative Medical Systems, Inc.
55 Steamwhistle Dr.
Ivyland,  PA  18974
Applicant Contact JOSEPH CATARIOUS
Correspondent
Innovative Medical Systems, Inc.
55 Steamwhistle Dr.
Ivyland,  PA  18974
Correspondent Contact JOSEPH CATARIOUS
Regulation Number864.3800
Classification Product Code
KPA  
Date Received02/24/1988
Decision Date 04/27/1988
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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