Product code DOG— Clinical Toxicology

FDA has cleared 5 devices under product code DOG between 1976 and 1981, 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.

• 19811 clearance
• 19801 clearance
• 19781 clearance
• 19762 clearances

• Syva Co.1 clearance
• Ortho Diagnostics, Inc.1 clearance
• Diagnostic Corp. of America1 clearance
• Dade, Baxter Travenol Diagnostics, Inc.1 clearance
• American Dade1 clearance

• K810477 — DCA DIGOX-SYN RIA TESTDiagnostic Corp. of America·1981-03-11
• K803045 — IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.American Dade·1980-12-22
• K781335 — DIGOXIN RIA (PEG) KITOrtho Diagnostics, Inc.·1978-08-31
• K760709 — EMIT DIGOKIN ASSAYSyva Co.·1976-10-21
• K760416 — DATA-TOPE SYSTEM DIGOXIN RIADade, Baxter Travenol Diagnostics, Inc.·1976-08-23