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510(k) K911444

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM by Wampole Laboratories — Product Code LFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1991
Date Received
April 1, 1991
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

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  • K781794 — BETA-TEC (December 29, 1978)
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Other clearances for product code LFX

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  • K243168 — Alinity i Rubella IgG (June 20, 2025)
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  • 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)