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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K112394 B. Purpose for Submission:
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Document Date: 2012-01-27 15:10:15

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File Size: 277,73 KB

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City

Detected / Indeterminate / /

Company

IgG / Focus Diagnostics’ Reference Laboratory / Focus Diagnostics Inc. / /

IndustryTerm

diluted acid stop solution / /

MedicalCondition

JCV infection / HIV / multiple sclerosis / disease / infection / MS / infectious agents / progressive multifocal leukoencephalopathy development / /

Organization

Social Democrats / /

Person

Max Mean / John Cunningham / /

Product

Methylprednisolone / CV-90 / Ibuprofen / Concomitant Medication / PATIENTS REPORTING MEDICATION USE PATIENTS NOT REPORTING MEDICATION / Amoxicillin / ANY time point PATIENTS REPORTING MEDICATION USE PATIENTS NOT REPORTING MEDICATION / /

Technology

antibodies / produced using normal human serum containing IgG antibodies / /

SocialTag