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510(k) K921573

RUBELLA IGM by Clark Laboratories, Inc. — Product Code LFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1992
Date Received
April 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
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)
  • K921572 — ENCORE SM (December 1, 1992)
  • K921870 — ENCORE SM/RNP (December 1, 1992)
  • K922340 — ENCORE SS-B (October 16, 1992)

Other clearances for product code LFX

  • K250588 — Access Rubella IgG (November 17, 2025)
  • K243168 — Alinity i Rubella IgG (June 20, 2025)
  • K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM (September 6, 2012)
  • K093101 — MAGO 4S (January 21, 2011)
  • K092587 — BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION S (December 3, 2010)
  • K092322 — ELECSYS RUBELLA IGM IMMUNOASSAY (March 12, 2010)
  • K080766 — VIDAS RUB IGG (December 23, 2008)
  • K072617 — ELECSYS RUBELLA IGG IMMUNOASSAY (December 5, 2008)
  • K073390 — DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS (November 21, 2008)
  • K063186 — ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM (March 21, 2007)