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510(k) K962469

ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY by American Laboratory Products Co., Ltd. — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1996
Date Received
June 25, 1996
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

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  • K962062 — ORGENTEC ANTI-SM ELISA (November 18, 1996)
  • K962057 — ORGENTEC ANTI-RNP/SM ELISA (November 18, 1996)
  • K962052 — ORGENTEC ABTI-SS-BB(LA) ELISA (November 15, 1996)

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