Product code DKN— Clinical Toxicology

FDA has cleared 4 devices under product code DKN between 1981 and 1991, filed by 2 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.

• 19911 clearance
• 19881 clearance
• 19831 clearance
• 19811 clearance

• Roche Diagnostic Systems, Inc.2 clearances
• Hoffmann-La Roche, Inc.2 clearances

• K914468 — ABUSCREEN(R) ONLINE(TM) FOR BARBITURATESRoche Diagnostic Systems, Inc.·1991-10-30
• K881816 — ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATESRoche Diagnostic Systems, Inc.·1988-07-28
• K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATEHoffmann-La Roche, Inc.·1983-03-10
• K812988 — AGGLUTEX BARBITURATES TEST KITHoffmann-La Roche, Inc.·1981-12-31