Atlas FDA

EL-ACL SCREEN; EL-ACL IGM, IGG, IGA

FDA 510(k) clearance K060176 · decided 2006-02-07

Clearance details

K-number
K060176
Device name
EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
Applicant
Theratest Laboratories, Inc.
Decision
Substantially Equivalent
Date received
2006-01-23
Decision date
2006-02-07
Days to decision
15 days
Clearance type
Special
Product code
MID
Device class
2
Regulation number
866.5660
Medical specialty
Immunology
Advisory committee
Immunology
Location
Lombard, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological te recall (Z-0835-06)Thera Test Laboratories, Inc.2006-05-04