Product code DNL— Clinical Toxicology

FDA has cleared 8 devices under product code DNL between 1977 and 1985, filed by 8 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.

• 19852 clearances
• 19812 clearances
• 19801 clearance
• 19791 clearance
• 19781 clearance
• 19771 clearance

• Wien Laboratories, Inc.1 clearance
• Nuclear Diagnostics, Inc.1 clearance
• New England Nuclear1 clearance
• M Nobird, Inc.1 clearance
• Immuno Assay Corp.1 clearance
• E. R. Squibb & Sons, Inc.1 clearance
• Clinical Assays, Inc.1 clearance
• American Diagnostic Corp.1 clearance

• K852343 — DIG RADIOIMMUNOASSAY TEST SYSTEMM Nobird, Inc.·1985-07-09
• K852291 — TIPSEP DIGOXIN RIANuclear Diagnostics, Inc.·1985-06-25
• K811212 — DIGOXIN (RIA) KITImmuno Assay Corp.·1981-05-21
• K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KITE. R. Squibb & Sons, Inc.·1981-04-21
• K802841 — DIGOXIN RADIOIMMUNOASSAY KITAmerican Diagnostic Corp.·1980-12-18
• K781834 — TEST SET, 125 I-DIGOXINWien Laboratories, Inc.·1979-01-03
• K781495 — RIANEN ASSAY SYSTEM, 125I KITNew England Nuclear·1978-09-14
• K772110 — IN VITRO DIGOXIN RIA TESTClinical Assays, Inc.·1977-11-22