Product code DAS— Immunology
AMINOGLYCOSIDE CONTROLS
- Classification name
- Igg (Fc Fragment Specific), Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5530
- Advisory panel
- Immunology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code DAS
FDA has cleared devices under product code DAS between 1976 and 1998, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1998
- 1994
- 1989
- 1979
- 1976
Top applicants under product code DAS
Recent clearances under product code DAS
- K982023 — PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
- K944876 — HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT
- K943098 — HUMAN IGG SUBCLASSES ELISA COMBI KIT
- K943205 — HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)
- K895600 — HUMAN (IGG) SUBCLASS (EIA) KIT
- K790708 — ANTISERUM TO HUMAN IG G FC FRAGMENTS
- K790715 — ANTISERUM TO HUMAN FC
- K761156 — AMINOGLYCOSIDE CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.