Atlas FDA

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k) clearance K001574 · decided 2000-06-09

Clearance details

K-number
K001574
Device name
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
Applicant
Axis-Shield
Decision
Substantially Equivalent
Date received
2000-05-22
Decision date
2000-06-09
Days to decision
18 days
Clearance type
Traditional
Product code
MID
Device class
2
Regulation number
866.5660
Medical specialty
Immunology
Advisory committee
Immunology
Location
Dundee Tayside, Scotland, GB
Third-party review
No
Expedited review
No

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ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (K102425)Zeus Scientific, Inc.2011-12-12
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EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (K060176)Theratest Laboratories, Inc.2006-02-07
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Recalls involving this device

RecordFirmDate
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection recall (Z-2920-2018)Euro Diagnostica AB2018-08-23
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection recall (Z-2921-2018)Euro Diagnostica AB2018-08-23