Product code DGO— Immunology
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
- Classification name
- Ige, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code DGO
FDA has cleared devices under product code DGO between 1980 and 1995, 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.
Clearances per year
- 1995
- 1992
- 1991
- 1989
- 1987
- 1986
- 1985
- 1983
- 1982
- 1980
Top applicants under product code DGO
Recent clearances under product code DGO
- K943194 — IMMULITE(R) ALLERGY FOOD PANEL FP5E
- K920087 — IGE EIA TEST KIT
- K911511 — ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
- K894039 — QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
- K893125 — BECKMAN EPSILON(TM) IGE REAGENT KIT
- K872801 — ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5
- K860851 — ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
- K853607 — ALLERG-E IGE ENZYME IMMUNOASSAY KIT
- K831984 — POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE
- K831987 — EPSILON IGE TEST KIT
- K831774 — LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-
- K830653 — POLYSTYRENE MICROTITER PLATE IMMUNOSORB
- K830495 — POLYSTYRENE MICROTITER PLATE IMMUNOSOR
- K821094 — IP SPECIFIC E
- K800995 — IMMUNOGLOBULIN E TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.