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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Purpose Reagent
510(k) Number K822326
Device Name BLENDED DETERGENT-78N 1912-1
Applicant
Interscience, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Interscience, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.4010
Classification Product Code
PPM  
Date Received08/03/1982
Decision Date 10/18/1982
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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