Product code DLN— Clinical Toxicology

FDA has cleared 4 devices under product code DLN between 1976 and 1995, filed by 4 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.

• 19951 clearance
• 19921 clearance
• 19791 clearance
• 19761 clearance

• Tecknam, Inc.1 clearance
• Roche Diagnostic Systems, Inc.1 clearance
• J.T. Baker Chemical Co.1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance

• K950134 — URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGEE.I. Dupont DE Nemours & Co., Inc.·1995-03-21
• K924113 — ABUSCREEN ONLINE FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.·1992-12-28
• K792429 — HIM TEST COCAINETecknam, Inc.·1979-12-07
• K760401 — COCAINE KIT, TOXI-PAKJ.T. Baker Chemical Co.·1976-08-26