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510(k) K962926

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1996
Date Received
July 29, 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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