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510(k) K032796

IBL C3D-CIC EIA TEST by Ibl GmbH — Product Code CZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2004
Date Received
September 8, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (July 22, 2004)
  • K033786 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIV (February 27, 2004)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)

Other clearances for product code CZW

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  • K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (March 19, 2007)
  • K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL (September 22, 2006)
  • K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (May 2, 2005)
  • K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMA (October 19, 2004)
  • K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C (August 7, 2003)
  • K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM (November 29, 2001)
  • K010326 — WAKO AUTOKIT C3 (June 25, 2001)
  • K000469 — RANDOX COMPLEMENT C3 (March 27, 2000)
  • K994296 — DIMENSION C3 FLEX REAGENT CARTRIDGE (March 1, 2000)