Atlas FDA

REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

FDA 510(k) clearance K032868 · decided 2003-10-14

Clearance details

K-number
K032868
Device name
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
Applicant
Corgenix, Inc.
Decision
Substantially Equivalent
Date received
2003-09-15
Decision date
2003-10-14
Days to decision
29 days
Clearance type
Special
Product code
MID
Device class
2
Regulation number
866.5660
Medical specialty
Immunology
Advisory committee
Immunology
Location
Westminster, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. recall (Z-1145-2010)Bio-Rad Laboratories Inc2010-03-16