FDA 510(k) Applications for Medical Device Product Code "DLI"
(Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase)

FDA 510(k) Number Applicant Device Name Decision Date
K771024 AMERICAN MONITOR CORP. CHOLINESTERASE REAGENT SYSTEM 07/15/1977
K950180 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD 03/15/1995
K860641 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 04/03/1986
K930208 HERAEUS KULZER, INC. CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO 04/20/1993
K833062 STERLING BIOCHEMICAL, INC. SERUM CHOLINESTERASE REAGENT SET 11/25/1983
K860350 STERLING DIAGNOSTICS, INC. SERUM CHOLINESTERASE REAGENT SET 04/24/1986


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact