Product code DLF— Clinical Toxicology

FDA has cleared 9 devices under product code DLF between 1978 and 1988, filed by 5 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.

• 19881 clearance
• 19851 clearance
• 19841 clearance
• 19833 clearances
• 19791 clearance
• 19782 clearances

• Syva Co.5 clearances
• Miles Laboratories, Inc.1 clearance
• Em Diagnostic Systems, Inc.1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance
• Abbott Laboratories1 clearance

• K881607 — EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647Em Diagnostic Systems, Inc.·1988-06-01
• K850174 — TDX ETHOSUXIMIDEAbbott Laboratories·1985-02-06
• K844204 — EMIT QST ETHOSUXIMIDE ASSAYSyva Co.·1984-12-11
• K832797 — MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAYSyva Co.·1983-09-29
• K823801 — AMES TDA ETHOSUXIMIDE TESTMiles Laboratories, Inc.·1983-01-14
• K823745 — ADVANCE EMIT-AED ETHOSUXIMIDESyva Co.·1983-01-07
• K792584 — ACA ETHOSURIMIDE TEST PACKE.I. Dupont DE Nemours & Co., Inc.·1979-12-31
• K780380 — ANALYZER, FAST, CENTRIFUGAL, GEMSAECSyva Co.·1978-04-12
• K780461 — ANALYZER-SUPPLEMENT, KINETIC, LKB 2086Syva Co.·1978-04-12