NBS · Class II · 21 CFR 866.5660

FDA Product Code NBS: Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1)

Leading manufacturers include Inova Diagnostics, Inc. and Euroimmun US.

3
Total
3
Cleared
260d
Avg days
2000
Since

FDA 510(k) Cleared Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) Devices (Product Code NBS)

3 devices
1–3 of 3
Cleared Sep 06, 2017
QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
K163538
Inova Diagnostics, Inc.
Immunology · 264d
Cleared Sep 11, 2012
EUROIMMUN ANTI-LKM-1 ELISA(LGG)
K112223
Euroimmun US
Immunology · 406d
Cleared Jun 07, 2000
QUANTA LITE LKM-1 ELISA
K000535
Inova Diagnostics, Inc.
Immunology · 111d

About Product Code NBS - Regulatory Context