B-HCG HUMAN SERUM CONTROLS

Single (specified) Analyte Controls (assayed And Unassayed)

PYRAMID BIOLOGICAL CORP.

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

Pre-market Notification Details

Device IDK932479
510k NumberK932479
Device Name:B-HCG HUMAN SERUM CONTROLS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys,  CA  91401
ContactJeanette Poretta
CorrespondentJeanette Poretta
PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 Van Nuys,  CA  91401
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-24
Decision Date1993-12-02

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