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510(k) K902793

RUBELLA IGG by Pharmacia Diagnostics, Inc. — Product Code LFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1990
Date Received
June 26, 1990
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 Pharmacia Diagnostics, Inc.

  • K052793 — IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, (February 7, 2006)
  • K051218 — MODIFICATION TO: UNICAP SPECIFIC IGE (June 9, 2005)
  • K921011 — PHARMACIA CMV IGM ELISA (July 27, 1992)
  • K920702 — TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO (July 8, 1992)
  • K915348 — EBV-VCA IGM ELISA (February 14, 1992)
  • K914022 — SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS (January 27, 1992)
  • K912026 — DELFIA(R) 17 -OH-PROGESTERON KIT (June 25, 1991)
  • K902792 — TOXOPLASMA GONDII IGG (July 24, 1990)

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)