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510(k) K925355

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

K925355 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on July 12, 1994. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Princeton Biomedix has at least 10 other 510(k) clearances on record.

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

Other clearances by Princeton Biomedix

  • K942052 — LIFESIGN MI MYOGLOBIN (February 7, 1995)
  • K930185 — OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP (March 4, 1993)
  • K925183 — BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST (February 23, 1993)
  • K926308 — LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST (January 26, 1993)
  • K901011 — BIOSIGN HCG-ONE STEP PREGNANCY TEST (May 4, 1990)
  • K894750 — BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (October 18, 1989)
  • K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST (October 18, 1989)
  • K892654 — BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (June 19, 1989)
  • K761315 — ALKALINE PHOSPHATASE (ALP)/PNPP (February 24, 1977)
  • K760345 — TEST, LACTATE DEHYDROGENASE (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)

FDA data resources