KALLESTAD'S ENDOPLATE FACTOR B TEST

Factor B, Antigen, Antiserum, Control

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad's Endoplate Factor B Test.

Pre-market Notification Details

Device IDK811740
510k NumberK811740
Device Name:KALLESTAD'S ENDOPLATE FACTOR B TEST
ClassificationFactor B, Antigen, Antiserum, Control
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJZH  
CFR Regulation Number866.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-19
Decision Date1981-07-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.