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510(k) K021398

APL IGA ELISA KIT by Louisville Apl Diagnostics, Inc. — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2002
Date Received
May 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Anticardiolipin Immunological
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Louisville Apl Diagnostics, Inc.

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  • K933588 — APHLELISA KIT (October 13, 1994)

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  • K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (February 7, 2006)