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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassettes, Tissue
510(k) Number K862457
Device Name LYNX EL MICROSCOPY TISSUE PROCESSOR
Applicant
Australian Biomedical Corporation , Ltd.
39 Dehavilland Rd.
Mordialloc, Vic. 3195
Australia,  AU
Applicant Contact J. D COOK
Correspondent
Australian Biomedical Corporation , Ltd.
39 Dehavilland Rd.
Mordialloc, Vic. 3195
Australia,  AU
Correspondent Contact J. D COOK
Regulation Number864.3010
Classification Product Code
IDZ  
Date Received06/30/1986
Decision Date 07/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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