HEPATITIS NEGATIVE CONTROL

Kit, Serological, Negative Control

PYRAMID BIOLOGICAL CORP.

The following data is part of a premarket notification filed by Pyramid Biological Corp. with the FDA for Hepatitis Negative Control.

Pre-market Notification Details

Device IDK962399
510k NumberK962399
Device Name:HEPATITIS NEGATIVE CONTROL
ClassificationKit, Serological, Negative Control
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 CodeMJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-21
Decision Date1996-08-02

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