ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)

Antinuclear Antibody, Antigen, Control

IMMCO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Antinuclear Antibody (ana) Test (hep-2 Cells).

Pre-market Notification Details

Device IDK883883
510k NumberK883883
Device Name:ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
ClassificationAntinuclear Antibody, Antigen, Control
Applicant IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo,  NY  14223
ContactRussell Nisengard
CorrespondentRussell Nisengard
IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo,  NY  14223
Product CodeLKJ  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-13
Decision Date1988-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845714003530 K883883 000
00845714000928 K883883 000
00845714000904 K883883 000
00845714000898 K883883 000
00845714000881 K883883 000
00845714000874 K883883 000
00845714000867 K883883 000
00845714000843 K883883 000
00845714000836 K883883 000
00845714000829 K883883 000
00845714000249 K883883 000
00845714000010 K883883 000
00845714001932 K883883 000
00845714001949 K883883 000
00845714003479 K883883 000
00845714003233 K883883 000
00845714003226 K883883 000
00845714003223 K883883 000
00845714003219 K883883 000
00845714002182 K883883 000
00845714002120 K883883 000
00845714002007 K883883 000
00845714001970 K883883 000
00845714001963 K883883 000
00845714001956 K883883 000
00845714000003 K883883 000

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