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510(k) K931543

ENCORE ENA COMBINED EIA by Clark Laboratories, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1993
Date Received
March 29, 1993
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 Clark Laboratories, Inc.

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  • K973123 — EA-D IGG ELISA TEST SYSTEM (March 26, 1998)
  • K925826 — ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA (January 26, 1993)
  • K923537 — ENCORE DS-DNA (December 23, 1992)
  • K921870 — ENCORE SM/RNP (December 1, 1992)
  • K921572 — ENCORE SM (December 1, 1992)
  • K922340 — ENCORE SS-B (October 16, 1992)
  • K922157 — ENCORE SS-A (October 13, 1992)

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