Atlas FDA

HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS

FDA 510(k) clearance K122304 · decided 2013-04-15

Clearance details

K-number
K122304
Device name
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
Applicant
The Binding Site Group , Ltd.
Decision
Substantially Equivalent
Date received
2012-08-01
Decision date
2013-04-15
Days to decision
257 days
Clearance type
Traditional
Product code
DBA
Device class
2
Regulation number
866.5250
Medical specialty
Immunology
Advisory committee
Immunology
Location
Birmingham, GB
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
OPTILITE C1 INACTIVATOR KIT (K141100)The Binding Site Group , Ltd.2014-07-18
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

Recalls involving this device

No recalls on record reference this clearance.