KTO · Class I · 21 CFR 866.5530

FDA Product Code KTO: Reagent, Immunoassay, Igg

Leading manufacturers include Reagents Applications, Inc. and Kallestad Laboratories, Inc..

2
Total
2
Cleared
25d
Avg days
1985
Since

FDA 510(k) Cleared Reagent, Immunoassay, Igg Devices (Product Code KTO)

2 devices
1–2 of 2
Cleared Aug 01, 1989
RAICHEM(TM) SPIA(TM) IGG REAGENTS
K894416
Reagents Applications, Inc.
Chemistry · 15d
Cleared Dec 11, 1985
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
K854483
Kallestad Laboratories, Inc.
Immunology · 34d

About Product Code KTO - Regulatory Context