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510(k) K951363

CARDIOLIPIN IGG,M,A EIA TEST SYSTEM by Immunoprobe, Inc. — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1995
Date Received
March 24, 1995
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 Immunoprobe, Inc.

  • K972406 — ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (December 22, 1997)
  • K971393 — MYCOPLASMA IGG ELISA TEST SYSTEM (July 14, 1997)
  • K961764 — PR-3 ELISA TEST SYSTEM (August 19, 1996)
  • K961765 — MPO ELISA TEST SYSTEM (August 19, 1996)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K952521 — CARDIOLIPIN IGM EIA TEST SYSTEM (February 9, 1996)
  • K952522 — CARDIOLIPIN IGA EIA TEST SYSTEM (February 9, 1996)
  • K952523 — CARDIOLIPIN IGG EIA TEST KIT (February 9, 1996)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)

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  • K103834 — BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (March 30, 2012)
  • K102425 — ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (December 12, 2011)
  • K091845 — CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (June 7, 2010)
  • K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (March 11, 2010)
  • K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (February 7, 2006)