Product code DML— Clinical Toxicology

FDA has cleared 13 devices under product code DML between 1984 and 2001, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20011 clearance
• 20001 clearance
• 19961 clearance
• 19952 clearances
• 19931 clearance
• 19911 clearance
• 19881 clearance
• 19871 clearance
• 19861 clearance
• 19843 clearances

• Syva Co.3 clearances
• Abbott Laboratories2 clearances
• Toxi-Lab, Inc.1 clearance
• Sigma Diagnostics, Inc.1 clearance
• Reagents Applications, Inc.1 clearance
• Em Diagnostic Systems, Inc.1 clearance
• Boehringer Mannheim Corp.1 clearance
• Ansys, Inc.1 clearance
• American Monitor Corp.1 clearance
• American Dade1 clearance

• K013538 — ETHANOLAbbott Laboratories·2001-12-14
• K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULSyva Co.·2000-02-01
• K963197 — ON.SITE ALCOHOLAnsys, Inc.·1996-09-19
• K953765 — AXSYM REA ETHANOLAbbott Laboratories·1995-09-27
• K952839 — BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAYBoehringer Mannheim Corp.·1995-08-24
• K923337 — ON*SITE ALCOHOLToxi-Lab, Inc.·1993-01-12
• K914777 — SIGMA PROCEDURE NO. 333-UVSigma Diagnostics, Inc.·1991-12-27
• K874382 — RAICHEM(TM) ALCOHOL REAGENTReagents Applications, Inc.·1988-01-11
• K872180 — KINETIC 610 ETHANOLAmerican Monitor Corp.·1987-07-07
• K863419 — EMDS(TM) ALCOHOL TESTPACKS, #67691/95Em Diagnostic Systems, Inc.·1986-09-29
• K840769 — PARAMAX ALCOHOL REAGENTAmerican Dade·1984-04-13
• K840400 — EMIT ST SERUM ETHYL ALCOHOL ASSAYSyva Co.·1984-03-23
• K840171 — EMIT ST URINE ETHYL ALCOHOL ASSAYSyva Co.·1984-03-19