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510(k) K000733

QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA by Inova Diagnostics, Inc. — Product Code NBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2001
Date Received
March 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Device Class
Class II
Regulation Number
866.5785
Review Panel
IM
Submission Type

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Other clearances for product code NBT

  • K071711 — ASCA-CHEK (November 7, 2007)
  • K051927 — TECHLAB ASCA-CHEK (April 6, 2006)
  • K051492 — AESKULISA ASCA A (November 14, 2005)
  • K042579 — BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT (July 28, 2005)
  • K032850 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) (March 18, 2004)
  • K032860 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) (March 18, 2004)
  • DEN000007 — QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (August 16, 2000)