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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 K860793
Device Name CAMCO STAIN PAK
Applicant
Cambridge Chemical Products, Inc.
6880 Northwest 17th Ave.
Ft. Lauderdale,  FL  33309
Applicant Contact JACK H GOLD
Correspondent
Cambridge Chemical Products, Inc.
6880 Northwest 17th Ave.
Ft. Lauderdale,  FL  33309
Correspondent Contact JACK H GOLD
Regulation Number864.1850
Classification Product Code
IAF  
Date Received03/04/1986
Decision Date 03/18/1986
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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