RADIOASSAY, CONTROL SERUM I, II, III

Whole Human Serum, Antigen, Antiserum, Control

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Radioassay, Control Serum I, Ii, Iii.

Pre-market Notification Details

Device IDK790298
510k NumberK790298
Device Name:RADIOASSAY, CONTROL SERUM I, II, III
ClassificationWhole Human Serum, Antigen, Antiserum, Control
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDGR  
CFR Regulation Number866.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-02-12
Decision Date1979-04-04

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