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510(k) K946215

CARDIOLIPIN G EIA TEST SYSTEM by Hogan & Hartson — Product Code MID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1996
Date Received
December 21, 1994
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 Hogan & Hartson

  • K974168 — COOPERSURGICAL INFRARED COAGULATOR (January 23, 1998)
  • K973849 — BIOABSORBABLE BANKART TACK (January 6, 1998)
  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K950169 — RIBOSOMAL P EIA TEST SYSTEM (May 23, 1996)
  • K942389 — TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (February 16, 1996)
  • K946217 — CARDIOLIPIN M EIA TEST SYSTEM (January 24, 1996)
  • K946216 — CARDIOLIPIN A EIA TEST SYSTEM (January 24, 1996)
  • K946186 — CHAL-2500 (August 14, 1995)
  • K941566 — COMPUSPEAK (June 30, 1995)
  • K950110 — MARDX MITOCHONDRIA EIA TEST SYSTEM (May 15, 1995)

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  • 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)