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510(k) K051492

AESKULISA ASCA A by Aesku, Inc. — Product Code NBT

K051492 is an FDA 510(k) premarket notification submitted by Aesku, Inc. for the device "AESKULISA ASCA A". The FDA issued a decision of Substantially Equivalent on November 14, 2005. The device falls under product code NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)), a Class II device regulated under 21 CFR 866.5785. Aesku, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2005
Date Received
June 6, 2005
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

Other clearances by Aesku, Inc.

  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)
  • K042644 — AESKULISA TTG A AND AESKULISA TTG G (June 1, 2005)
  • K040953 — AESKULISA ANA HEP-2 (June 23, 2004)
  • K040463 — AESKULISA CARDIOLIPIN AGM (May 12, 2004)
  • K032469 — AESKULISA ANA 8PRO (December 16, 2003)

Other clearances for product code NBT

  • K071711 — ASCA-CHEK (November 7, 2007)
  • K051927 — TECHLAB ASCA-CHEK (April 6, 2006)
  • 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)
  • DEN000007 — QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (August 16, 2000)

FDA data resources