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510(k) K984102

ACL/APS FACS KIT by Louisville Apl Diagnostics, Inc. — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1999
Date Received
November 17, 1998
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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  • K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (February 7, 2006)