CMV IGG HUMAN SERUM CONTROLS

Antiserum, Cf, Cytomegalovirus

PYRAMID BIOLOGICAL CORP.

The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Cmv Igg Human Serum Controls.

Pre-market Notification Details

Device IDK951800
510k NumberK951800
Device Name:CMV IGG HUMAN SERUM CONTROLS
ClassificationAntiserum, Cf, Cytomegalovirus
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 CodeGQI  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-18
Decision Date1995-11-16

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