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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 K781384
Device Name WRIGHT RAPID STAIN
Applicant
Mfg Chemists, Inc.
5767 Thunderbird Rd.
Indianapolis,  IN  46236
Correspondent
Mfg Chemists, Inc.
5767 Thunderbird Rd.
Indianapolis,  IN  46236
Regulation Number864.1850
Classification Product Code
IAF  
Date Received08/11/1978
Decision Date 08/21/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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