Atlas FDA

BINDAZYME CLQ CIC EIA KIT

FDA 510(k) clearance K031563 · decided 2003-09-10

Clearance details

K-number
K031563
Device name
BINDAZYME CLQ CIC EIA KIT
Applicant
The Binding Site, Ltd.
Decision
Substantially Equivalent
Date received
2003-05-19
Decision date
2003-09-10
Days to decision
114 days
Clearance type
Traditional
Product code
DAK
Device class
2
Regulation number
866.5240
Medical specialty
Immunology
Advisory committee
Immunology
Location
Santa Monica, CA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
IBL C1Q-CIC CIA TEST (K032254)Ibl GmbH2003-08-29
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HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (K951968)Kent Laboratories, Inc.1995-05-30
C1 RID KIT (K914388)The Binding Site, Ltd.1991-10-28
CIRCULATING IMMUNE COMPLEXES CONTROLS (K882829)Cytotech, Inc.1988-08-04
SANASSAY IC TEST (K860996)Scientific Sales Intl., Inc.1987-03-30
IC MICROASSAY (K864312)Diamedix Corp.1987-01-09
CYTOTECH CIC ENZYME IMMUNOASSAY (K862649)Cytotech, Inc.1986-09-04
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT (K861499)Biostar Medical Products, Inc.1986-06-20
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT (K853697)Biostar Medical Products, Inc.1985-12-16

Recalls involving this device

RecordFirmDate
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: M recall (Z-1942-2010)Inova Diagnostics Incorporated2010-06-30