AVL OPTI CRITICAL CARE ANALYZER

Electrode, Ion Specific, Potassium

AVL SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Opti Critical Care Analyzer.

Pre-market Notification Details

Device IDK974784
510k NumberK974784
Device Name:AVL OPTI CRITICAL CARE ANALYZER
ClassificationElectrode, Ion Specific, Potassium
Applicant AVL SCIENTIFIC CORP. 33 MANSELL COURT Roswell,  GA  30076 -4807
ContactRandy Byrd
CorrespondentMike Carrasquillo
AVL SCIENTIFIC CORP. 235 Hembree Park Drive Roswell,  GA  30076
Product CodeCEM  
Subsequent Product CodeCHL
Subsequent Product CodeGKR
Subsequent Product CodeGLY
Subsequent Product CodeJGS
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-22
Decision Date1998-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00894472000244 K974784 000
00894472000237 K974784 000

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