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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 K000238
Device Name HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
Applicant
Mrl Diagnostics
10703 Progress Way
Cypress,  CA  90630 -4737
Applicant Contact MICHAEL J WAGNER
Correspondent
Mrl Diagnostics
10703 Progress Way
Cypress,  CA  90630 -4737
Correspondent Contact MICHAEL J WAGNER
Regulation Number866.3305
Classification Product Code
LGC  
Date Received01/27/2000
Decision Date 04/14/2000
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
Recalls CDRH Recalls
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