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510(k) K894546

IMMUNODOT RUBELLA TEST by General Biometrics, Inc. — Product Code LFX

K894546 is an FDA 510(k) premarket notification submitted by General Biometrics, Inc. for the device "IMMUNODOT RUBELLA TEST". The FDA issued a decision of Substantially Equivalent on October 16, 1989. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. General Biometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1989
Date Received
July 21, 1989
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 General Biometrics, Inc.

  • K924843 — IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL (December 1, 1992)
  • K920401 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST (August 20, 1992)
  • K920400 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST (August 20, 1992)
  • K911627 — IMMUNODOT BORRELIA (LYME) TEST (April 8, 1992)
  • K911599 — IMMUNOWELL LYME (P39 RECOMBINANT) TEST (December 30, 1991)
  • K911590 — IMMUNOWELL BORRELIA (LYME)TEST (December 20, 1991)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K911850 — IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST (May 7, 1991)
  • K911848 — IMMUNOWELL RNP/SM ANTIBODY TEST (May 7, 1991)
  • K911851 — IMMUNOWELL SM ANTIBODY TEST (May 7, 1991)

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