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510(k) K032469

AESKULISA ANA 8PRO by Aesku, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2003
Date Received
August 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Aesku, Inc.

  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)
  • K051492 — AESKULISA ASCA A (November 14, 2005)
  • 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)

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