KLP · Class II · 21 CFR 862.3035

FDA Product Code KLP: Amikacin Serum Assay

Leading manufacturers include Roche Diagnostics Corp., Bd Becton Dickinson Vacutainer Systems Preanalytic and Em Diagnostic Systems, Inc..

4
Total
4
Cleared
56d
Avg days
1978
Since

FDA 510(k) Cleared Amikacin Serum Assay Devices (Product Code KLP)

4 devices
1–4 of 4
Cleared Oct 10, 2003
ONLINE TDM AMIKA
K032279
Roche Diagnostics Corp.
Toxicology · 78d
Cleared Oct 29, 1987
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
K873426
Em Diagnostic Systems, Inc.
Toxicology · 65d
Cleared May 23, 1979
BACTEC
K790899
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 14d

About Product Code KLP - Regulatory Context