DLI · Class I · 21 CFR 862.3240

FDA Product Code DLI: Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

Leading manufacturers include American Monitor Corp., Sterling Diagnostics, Inc. and Em Diagnostic Systems, Inc..

6
Total
6
Cleared
66d
Avg days
1977
Since

FDA 510(k) Cleared Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase Devices (Product Code DLI)

6 devices
1–6 of 6
Cleared Mar 15, 1995
DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD
K950180
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 57d
Cleared Apr 20, 1993
CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO
K930208
Heraeus Kulzer, Inc.
Toxicology · 95d
Cleared Apr 24, 1986
SERUM CHOLINESTERASE REAGENT SET
K860350
Sterling Diagnostics, Inc.
Chemistry · 84d
Cleared Apr 03, 1986
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
K860641
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Jul 15, 1977
CHOLINESTERASE REAGENT SYSTEM
K771024
American Monitor Corp.
Chemistry · 37d

About Product Code DLI - Regulatory Context