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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Microbiologic
510(k) Number K873413
Device Name GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR
Applicant
Lakewood Biochemical Co., Inc.
2111 Irving Blvd.
Dallas,  TX  75207
Applicant Contact JOHN E PEDIGO
Correspondent
Lakewood Biochemical Co., Inc.
2111 Irving Blvd.
Dallas,  TX  75207
Correspondent Contact JOHN E PEDIGO
Regulation Number864.1850
Classification Product Code
JTS  
Date Received08/24/1987
Decision Date 10/06/1987
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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