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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Digoxin
510(k) Number K901216
Device Name ENZYMUN TEST(R) DIGOXIN
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Applicant Contact CHERI EMMONS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Correspondent Contact CHERI EMMONS
Regulation Number862.3320
Classification Product Code
KXT  
Date Received03/14/1990
Decision Date 05/31/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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