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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 K863798
Device Name FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
Applicant
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Applicant Contact LOUISE HARRIS
Correspondent
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Correspondent Contact LOUISE HARRIS
Regulation Number866.3175
Classification Product Code
LKQ  
Date Received09/29/1986
Decision Date 04/14/1987
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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