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510(k) K941624

RUBELLA IGG ELISA TEST by Gull Laboratories, Inc. — Product Code LFX

K941624 is an FDA 510(k) premarket notification submitted by Gull Laboratories, Inc. for the device "RUBELLA IGG ELISA TEST". The FDA issued a decision of Substantially Equivalent on August 4, 1995. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Gull Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1995
Date Received
April 4, 1994
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 Gull Laboratories, Inc.

  • K983541 — HSV 1+2 IGG ELISA TEST (February 26, 1999)
  • K971857 — MUMPS IGG ELISA TESTY (November 4, 1997)
  • K962343 — TOXO IGG ELISA TEST (March 24, 1997)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K940093 — EBV-EA(D) IGG ELISA TEST (September 15, 1995)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)
  • K941198 — EBV LGG ELISA TEST (August 23, 1995)
  • K932333 — PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (August 15, 1995)
  • K922759 — HSV-2 IGM ELISA TEST--MODIFICATION (October 5, 1992)
  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)

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