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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K922582
Device Name BARTELS CYTOMEGALOVIRUS IGG EIA
Applicant
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact NANCY MALLINAK
Correspondent
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact NANCY MALLINAK
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received05/27/1992
Decision Date 04/08/1993
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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