Product code DPO— Clinical Toxicology
AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM
- Classification name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code DPO
FDA has cleared devices under product code DPO between 1977 and 1991, filed by 13 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.
Clearances per year
- 1991
- 1987
- 1984
- 1983
- 1981
- 1980
- 1979
- 1977
Top applicants under product code DPO
Recent clearances under product code DPO
- K914833 — IMMULITE DIGOXIN
- K905719 — ECLIPSE ICA DIGOXIN
- K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
- K833842 — RIA COAT DIGOXIN
- K832163 — SOPHEIA DIGOXIN EIA KIT
- K830962 — IMMUCHEM COVALENT-COAT RIA KIT
- K811932 — COAT-A-COUNT DIGOXIN RIA
- K811776 — KALLESTAD QUANTICOAT 125 DIGOXIN
- K800205 — RIA PHASE DIGOXIN
- K791325 — AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM
- K791355 — VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT
- K771638 — IGOXIN SOLID PHASE RIA
- K770365 — RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO
- K770069 — DIGOXIN CLASP TM RIA KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.