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510(k) K924056

ENCORE RHEUMATOID FACTOR EIA by Clark Laboratories, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1992
Date Received
August 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

Other clearances by Clark Laboratories, Inc.

  • K980912 — VCA IGG ELISA TEST SYSTEM (July 22, 1998)
  • K980596 — VCA IGM ELISA TEST SYSTEM (July 22, 1998)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 1998)
  • K973123 — EA-D IGG ELISA TEST SYSTEM (March 26, 1998)
  • K931543 — ENCORE ENA COMBINED EIA (September 8, 1993)
  • 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)

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