TREPCHEK TREPONEMAL ANTIBODY EIA

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

PHOENIX BIOTECH CORP.

The following data is part of a premarket notification filed by Phoenix Biotech Corp. with the FDA for Trepchek Treponemal Antibody Eia.

Pre-market Notification Details

Device IDK001552
510k NumberK001552
Device Name:TREPCHEK TREPONEMAL ANTIBODY EIA
ClassificationEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant PHOENIX BIOTECH CORP. 53 CEDAR LAKE RD. Blairstown,  NJ  07825
ContactGary Lehnus
CorrespondentGary Lehnus
PHOENIX BIOTECH CORP. 53 CEDAR LAKE RD. Blairstown,  NJ  07825
Product CodeLIP  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-18
Decision Date2000-10-19

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