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510(k) K925355

BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST by Princeton Biomedix — Product Code LFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1994
Date Received
October 22, 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

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  • K926308 — LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST (January 26, 1993)
  • K901011 — BIOSIGN HCG-ONE STEP PREGNANCY TEST (May 4, 1990)
  • K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST (October 18, 1989)
  • K894750 — BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (October 18, 1989)
  • K892654 — BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (June 19, 1989)
  • K761315 — ALKALINE PHOSPHATASE (ALP)/PNPP (February 24, 1977)
  • K760346 — ASSAY FOR GAMMA GLUTAMYLTRANSFERASE (October 27, 1976)

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)