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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wright'S Stain
510(k) Number K852138
Device Name WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
Applicant
Canyon Diagnostics, Inc.
4081 E. La Palma Ave., Unit F
Anaheim,  CA  92807
Applicant Contact ANTHONY FALKOWSKI
Correspondent
Canyon Diagnostics, Inc.
4081 E. La Palma Ave., Unit F
Anaheim,  CA  92807
Correspondent Contact ANTHONY FALKOWSKI
Regulation Number864.1850
Classification Product Code
IAF  
Date Received05/16/1985
Decision Date 06/13/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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