Product code DBA— Immunology
ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)
- Classification name
- Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5250
- Advisory panel
- Immunology
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code DBA
FDA has cleared devices under product code DBA between 1978 and 2014, filed by 12 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
- 2014
- 2013
- 2007
- 2001
- 1997
- 1996
- 1995
- 1992
- 1987
- 1982
- 1978
Top applicants under product code DBA
Recent clearances under product code DBA
- K141100 — OPTILITE C1 INACTIVATOR KIT
- K122304 — HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
- K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
- K011780 — K-ASSAY C1-INA
- K003747 — C1-INHIBITOR MICROTITER ASSAY DEVICE
- K965024 — N-ASSAY TIA C1-INACTIVATOR TEST KIT
- K960257 — N ANTISERUM TO C1 INHIBITOR
- K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
- K915431 — COMPLEMENT C1 INACTIVATOR KIT
- K872426 — CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
- K821898 — ORTHO CLASSICAL PATHWAY COMPL. TEST
- K781017 — ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)
- K780335 — LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.