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510(k) DEN000007

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

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 16, 2000
Date Received
July 18, 2000
Clearance Type
Post-NSE
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)
  • K000733 — QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA (May 21, 2001)