Product code DPB— Clinical Toxicology

FDA has cleared 10 devices under product code DPB between 1976 and 1985, 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.

• 19851 clearance
• 19823 clearances
• 19793 clearances
• 19772 clearances
• 19761 clearance

• Wien Laboratories, Inc.1 clearance
• Ventrex Laboratories, Inc.1 clearance
• Radioimmunoassay, Inc.1 clearance
• Pcl-Ria, Inc.1 clearance
• Nuclear Medical Laboratories, Inc.1 clearance
• Miles Laboratories, Inc.1 clearance
• Endocrine-Metabolic Center1 clearance
• Diagnostic Products Corp.1 clearance
• Cambridge Medical Technology1 clearance
• American Diagnostic Corp.1 clearance

• K853021 — OPTIMATE DIGOXIN TESTMiles Laboratories, Inc.·1985-08-07
• K823014 — DIGOXIN KITPcl-Ria, Inc.·1982-11-01
• K821811 — 125I DIGOXIN RADIOIMMUNOASSAY KITCambridge Medical Technology·1982-07-02
• K820274 — DIGOXIN RADIOIMMUNOASSAYAmerican Diagnostic Corp.·1982-02-23
• K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.·1979-11-13
• K790602 — RIA, DIGNXIN-125-IEndocrine-Metabolic Center·1979-07-30
• K790540 — RIA TEST KIT, CENTRIA DIGOXINVentrex Laboratories, Inc.·1979-04-23
• K772306 — 125I DIGOXIN TEST SETWien Laboratories, Inc.·1977-12-22
• K771525 — 125 I DIGOXIN RIA KITDiagnostic Products Corp.·1977-10-14
• K760883 — DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAYNuclear Medical Laboratories, Inc.·1976-11-19