KALLESTAD QUANTITOPE LOW LEVEL IGE REAG

Ige, 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 Quantitope Low Level Ige Reag.

Pre-market Notification Details

Device IDK811545
510k NumberK811545
Device Name:KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
ClassificationIge, Antigen, Antiserum, Control
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-01
Decision Date1981-06-24

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