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510(k) K911444

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM by Wampole Laboratories — Product Code LFX

K911444 is an FDA 510(k) premarket notification submitted by Wampole Laboratories for the device "RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 30, 1991. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Wampole Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1991
Date Received
April 1, 1991
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 Wampole Laboratories

  • K965129 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (March 26, 1997)
  • K965131 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (March 26, 1997)
  • K882896 — ONE-STEP HCG (October 31, 1988)
  • K883004 — MONO-PLUS(TM) (August 4, 1988)
  • K875101 — VIROGEN CMV ANTIBODY TEST (March 1, 1988)
  • K875161 — MAT (TM) MICROALBUMIN TEST (February 17, 1988)
  • K791309 — UCG-LYPHOTEST (July 30, 1979)
  • K790986 — RF CONTROLS (June 28, 1979)
  • K781794 — BETA-TEC (December 29, 1978)
  • K760336 — BIOCEPT-G (November 12, 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