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510(k) K001552

TREPCHEK TREPONEMAL ANTIBODY EIA by Phoenix Biotech Corp. — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2000
Date Received
May 18, 2000
Clearance Type
Traditional
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

Other clearances by Phoenix Biotech Corp.

  • K053570 — TREP-SURE TREPONEMAL ANTIBODY EIA (August 7, 2006)

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