Product code DON— Clinical Toxicology
CAMMADISK DIGOXIN
- Classification name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code DON
FDA has cleared devices under product code DON between 1976 and 1990, filed by 15 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
- 1990
- 1988
- 1984
- 1983
- 1982
- 1981
- 1980
- 1979
- 1978
- 1977
- 1976
Top applicants under product code DON
Recent clearances under product code DON
- K902861 — CIBA CORNING ACS DIGOXIN IMMUNOASSAY
- K881679 — CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
- K840461 — MAGIC 125I DIGOXIN RADIOIMMUNOASSAY
- K830533 — PHASE II DIGOXIN RADIOIMMUNOASSAY KIT
- K822053 — ZETAPHASE-DIG
- K821000 — ENZYMUNE-TEST DIGOXIN
- K810296 — DIGOXIN RIA ASSAY
- K803075 — DIGOXIN RIABEAD DIAGNOSTIC KIT
- K791549 — TECHNICON STAR SYSTEM
- K781660 — RIA, DIGOXIN
- K780475 — DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT
- K780207 — LIQUISOL DIGOXIN RIA TEST KIT
- K772422 — QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA
- K772098 — DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS
- K771255 — CEBTRIA DIGOXIN RIA
- K770269 — CAMMADISK DIGOXIN
- K760800 — SPAC DIGOXIN KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.