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510(k) K071219

ATHENA MULTI-LYTE GBM TEST SYSTEM by Zeus Scientific, Inc. — Product Code MVJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2007
Date Received
May 2, 2007
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

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Other clearances for product code MVJ

  • K072358 — BIOPLEX VASCULITIS KIT (October 31, 2007)
  • K011348 — PHASE II GBM IGG ANTIBODY EIA TEST (June 25, 2001)
  • 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)