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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tanks, Developing, Tlc
510(k) Number K812919
Device Name MULTI-GRAM DEVELOPING TANK R-12 & R-3
Applicant
Marion Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Marion Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2270
Classification Product Code
DKK  
Date Received10/19/1981
Decision Date 11/02/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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