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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K921939
Device Name SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
Applicant
Heraeus Kulzer, Inc.
P.O. Box 2004
Mishawaka,  IN  46546
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
P.O. Box 2004
Mishawaka,  IN  46546
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.3280
Classification Product Code
LAS  
Date Received04/24/1992
Decision Date 07/16/1992
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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