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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Chemical Solution
510(k) Number K860795
Device Name SPOTTEST CALCOFLUOR WHITE REAGENT
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Applicant Contact M. T ROBERT
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Correspondent Contact M. T ROBERT
Regulation Number864.1850
Classification Product Code
LED  
Date Received03/04/1986
Decision Date 03/12/1986
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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