Atlas FDA

N ANTISERUM TO C1 INHIBITOR

FDA 510(k) clearance K960257 · decided 1996-08-01

Clearance details

K-number
K960257
Device name
N ANTISERUM TO C1 INHIBITOR
Applicant
Behring Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1996-01-18
Decision date
1996-08-01
Days to decision
196 days
Clearance type
Traditional
Product code
DBA
Device class
2
Regulation number
866.5250
Medical specialty
Immunology
Advisory committee
Immunology
Location
Westwood, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Behring Diagnostics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
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
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.

PMA approvals by this applicant

RecordFirmDate
OPUS(R) CEA TEST SYSTEM (P920021/S001)Behring Diagnostics, Inc.1996-02-23