Product code DLP— Clinical Toxicology

FDA has cleared 5 devices under product code DLP between 1977 and 1989, 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.

• 19891 clearance
• 19811 clearance
• 19801 clearance
• 19791 clearance
• 19771 clearance

• Ventrex Laboratories, Inc.1 clearance
• Kallestad Laboratories, Inc.1 clearance
• Colony Laboratories, Inc.1 clearance
• Bio-Rad1 clearance
• Amersham Corp.1 clearance

• K894527 — FPR PHENYTOIN KITColony Laboratories, Inc.·1989-09-25
• K811775 — KALLESTAD ANTISERA TO PHENYTOINKallestad Laboratories, Inc.·1981-07-10
• K792640 — FLUOROMATIC PHENYTOIN FIABio-Rad·1980-01-11
• K791896 — CENTRIA PHENYTOIN RIA TEST SETVentrex Laboratories, Inc.·1979-10-17
• K770779 — PHENYTOIN RIA KITAmersham Corp.·1977-06-17