Atlas FDA

DBA

13 FDA 510(k) clearances · Product code

59 daysmedian time to decision
209 days90th percentile
13clearances measured

FDA profile

Official device name
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5250
Medical specialty
Immunology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
OPTILITE C1 INACTIVATOR KIT (K141100)The Binding Site Group , Ltd.2014-07-18
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (K122304)The Binding Site Group , Ltd.2013-04-15
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (K072965)Dade Behring, Inc.2007-12-21
K-ASSAY C1-INA (K011780)Kamiya Biomedical Co.2001-07-25
C1-INHIBITOR MICROTITER ASSAY DEVICE (K003747)Baxter Healthcare Corp2001-03-19
N-ASSAY TIA C1-INACTIVATOR TEST KIT (K965024)Crestat Diagnostics, Inc.1997-07-14
N ANTISERUM TO C1 INHIBITOR (K960257)Behring Diagnostics, Inc.1996-08-01
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (K951967)Kent Laboratories, Inc.1995-05-30
COMPLEMENT C1 INACTIVATOR KIT (K915431)The Binding Site, Ltd.1992-01-17
CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (K872426)Cytotech, Inc.1987-07-23
ORTHO CLASSICAL PATHWAY COMPL. TEST (K821898)Ortho Diagnostic Systems, Inc.1982-07-16
ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) (K781017)Icl Scientific1978-08-14
LAS-R HUMAN C1 ESTERASE INHIBITOR TEST (K780335)Hyland Therapeutic Div., Travenol Laboratories1978-03-22

Track DBA automatically

Every clearance here is in the API, with alerts when new ones post.