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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, Herpes Simplex Virus, Non-Specific
510(k) Number K922583
Device Name BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
Applicant
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact MALLINAK
Correspondent
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact MALLINAK
Regulation Number866.3305
Classification Product Code
LGC  
Date Received05/27/1992
Decision Date 09/28/1992
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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