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510(k) K120439

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG by Bio-Rad Laboratories, Inc. — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2012
Date Received
February 13, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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  • K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (January 20, 2012)
  • K102400 — SYPHILIS HEALTH CHECK (August 1, 2011)
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