QUANTAFLUOR FLUORESCENT TEST REAGENTS

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantafluor Fluorescent Test Reagents.

Pre-market Notification Details

Device IDK813592
510k NumberK813592
Device Name:QUANTAFLUOR FLUORESCENT TEST REAGENTS
ClassificationAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHN  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-28
Decision Date1982-01-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847865001724 K813592 000
00847865001717 K813592 000
00847865001700 K813592 000
00847865001694 K813592 000

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