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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 immunoabsorption assay, treponema pallidum
510(k) Number K001552
Device Name TREPCHEK TREPONEMAL ANTIBODY EIA
Applicant
PHOENIX BIOTECH CORP.
53 CEDAR LAKE RD.
BLAIRSTOWN,  NJ  07825
Applicant Contact Gary Lehnus
Correspondent
PHOENIX BIOTECH CORP.
53 CEDAR LAKE RD.
BLAIRSTOWN,  NJ  07825
Correspondent Contact Gary Lehnus
Regulation Number866.3830
Classification Product Code
LIP  
Date Received05/18/2000
Decision Date 10/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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