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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 K863550
Device Name POTASSIUM HYDROXIDE 10% W/V
Applicant
Reagent Laboratory, Inc.
300 E. Ottawa Ave.
Louisville,  KY  40209
Applicant Contact DONALD SKAGGS
Correspondent
Reagent Laboratory, Inc.
300 E. Ottawa Ave.
Louisville,  KY  40209
Correspondent Contact DONALD SKAGGS
Regulation Number864.4010
Classification Product Code
PPM  
Date Received09/12/1986
Decision Date 10/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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