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510(k) K873088

VIRGO(TM) RUBELLA IGG ELISA by Electro-Nucleonics Laboratories, Inc. — Product Code LFX

K873088 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics Laboratories, Inc. for the device "VIRGO(TM) RUBELLA IGG ELISA". The FDA issued a decision of Substantially Equivalent on September 9, 1987. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Electro-Nucleonics Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1987
Date Received
August 5, 1987
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 Electro-Nucleonics Laboratories, Inc.

  • K873925 — VIRGO(TM) MEASLES IGG ELISA (February 24, 1988)
  • K873617 — GEMSTAR II SYSTEM (October 19, 1987)
  • K873416 — MULTI-ACCESS REAGENT DISPENSER (October 9, 1987)
  • K873358 — GEMENI URIC ACID U.V. (September 11, 1987)
  • K871905 — TOXOPLASMA GONDII IGG ELISA (July 30, 1987)
  • K870928 — CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS (April 22, 1987)
  • K863874 — LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (November 13, 1986)
  • K862640 — AMYLASE LTS (September 9, 1986)
  • K853372 — GEMSTAR IPA THEOPHYLLINE TEST KIT (September 4, 1985)
  • K853373 — DELTA TROL I & II (August 23, 1985)

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