TRANSFERRIN NEPHELOMETRIC ASSAY

Transferrin, Antigen, Antiserum, Control

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Transferrin Nephelometric Assay.

Pre-market Notification Details

Device IDK772253
510k NumberK772253
Device Name:TRANSFERRIN NEPHELOMETRIC ASSAY
ClassificationTransferrin, Antigen, Antiserum, Control
Applicant KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDDG  
CFR Regulation Number866.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-09
Decision Date1977-12-22

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