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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm,If, Cytomegalovirus Virus
510(k) Number K854839
Device Name CYTOMEGELISA M TEST KIT
Applicant
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Applicant Contact PATRICIA B SHRADER
Correspondent
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Correspondent Contact PATRICIA B SHRADER
Regulation Number866.3175
Classification Product Code
LKQ  
Date Received12/04/1985
Decision Date 02/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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