ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Antigens, Iha, Toxoplasma Gondii

PYRAMID BIOLOGICAL CORP.

The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii.

Pre-market Notification Details

Device IDK952818
510k NumberK952818
Device Name:ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
ClassificationAntigens, Iha, Toxoplasma Gondii
Applicant PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys,  CA  91401
ContactJeanette R Porretta
CorrespondentJeanette R Porretta
PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys,  CA  91401
Product CodeGMM  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-20
Decision Date1995-11-20

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