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510(k) K011348

PHASE II GBM IGG ANTIBODY EIA TEST by Scimedx Corp. — Product Code MVJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2001
Date Received
May 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Scimedx Corp.

  • K011082 — TPO IGG ANTIBODY EIA TEST (June 6, 2001)
  • K010625 — EUROSPITAL EU-TTG IGA UMANA (April 24, 2001)
  • K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA (March 16, 2001)
  • K010289 — SCIMEDX PHASE II MPO IGG ANTIBODY EIA (March 7, 2001)
  • K002169 — GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002189 — GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002107 — IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CO (August 4, 2000)
  • K994379 — EU-TTG IGA ELISA (February 18, 2000)
  • K970198 — IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES (February 20, 1997)
  • K962360 — IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES (September 30, 1996)

Other clearances for product code MVJ

  • K071219 — ATHENA MULTI-LYTE GBM TEST SYSTEM (December 6, 2007)
  • K072358 — BIOPLEX VASCULITIS KIT (October 31, 2007)
  • K991890 — AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA (August 9, 1999)
  • K984619 — BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT (February 23, 1999)
  • K984336 — QUANTA LITE GBM ELISA (February 8, 1999)