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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution, Isotonic
510(k) Number K831200
Device Name IMMUNOHEMATOLOGICAL SALINE #97139
Applicant
Emd Chemicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Emd Chemicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.4010
Classification Product Code
JCE  
Date Received04/11/1983
Decision Date 05/09/1983
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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