NEG COMBO BREAKPOINT PANEL POS COMBO

Kit, Screening, Staphylococcus Aureus

AMERICAN MICRO SCAN

The following data is part of a premarket notification filed by American Micro Scan with the FDA for Neg Combo Breakpoint Panel Pos Combo.

Pre-market Notification Details

Device IDK854278
510k NumberK854278
Device Name:NEG COMBO BREAKPOINT PANEL POS COMBO
ClassificationKit, Screening, Staphylococcus Aureus
Applicant AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento,  CA  95819
ContactKrista L Underwood
CorrespondentKrista L Underwood
AMERICAN MICRO SCAN 855 57TH. ST. SUITE G Sacramento,  CA  95819
Product CodeJWX  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-10-24
Decision Date1986-03-04

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