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510(k) K951363

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

K951363 is an FDA 510(k) premarket notification submitted by Immunoprobe, Inc. for the device "CARDIOLIPIN IGG,M,A EIA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on October 13, 1995. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Immunoprobe, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K961765 — MPO ELISA TEST SYSTEM (August 19, 1996)
  • K961764 — PR-3 ELISA TEST SYSTEM (August 19, 1996)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K952522 — CARDIOLIPIN IGA EIA TEST SYSTEM (February 9, 1996)
  • K952523 — CARDIOLIPIN IGG EIA TEST KIT (February 9, 1996)
  • K952521 — CARDIOLIPIN IGM EIA TEST SYSTEM (February 9, 1996)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)

Other clearances for product code MID

  • K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (December 17, 2024)
  • K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (December 23, 2013)
  • K130528 — BIOPLEX 2200 APLS IGM (October 21, 2013)
  • K120817 — QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (February 26, 2013)
  • K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) (October 25, 2012)
  • 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)

FDA data resources