RNA MEDICAL'S EQUIL 55

Controls For Blood-gases, (assayed And Unassayed)

BIONOSTICS, INC.

The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Rna Medical's Equil 55.

Pre-market Notification Details

Device IDK922357
510k NumberK922357
Device Name:RNA MEDICAL'S EQUIL 55
ClassificationControls For Blood-gases, (assayed And Unassayed)
Applicant BIONOSTICS, INC. TWO CRAIG RD. Acton,  MA  01720
ContactBruce R Williams
CorrespondentBruce R Williams
BIONOSTICS, INC. TWO CRAIG RD. Acton,  MA  01720
Product CodeJJS  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-19
Decision Date1992-06-30

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