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510(k) K834032

RUBAQUICK DIAGNOSTIC KIT by Abbott Laboratories — Product Code GOL

K834032 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "RUBAQUICK DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on April 17, 1984. The device falls under product code GOL (Antigen, Ha (Including Ha Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1984
Date Received
November 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ha (Including Ha Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

Other clearances by Abbott Laboratories

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  • K243500 — ARCHITECT iGentamicin (July 9, 2025)
  • K243168 — Alinity i Rubella IgG (June 20, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K232669 — TBI (September 29, 2023)
  • K222850 — HAVAb IgG II (August 10, 2023)
  • K220031 — Alinity h-series System (August 4, 2023)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

Other clearances for product code GOL

  • K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAY (June 7, 1984)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)
  • K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (December 18, 1980)
  • K802339 — EIA RUBELLA-G (December 18, 1980)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)
  • K801098 — ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (September 16, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)
  • K800797 — MACRO-VUE RUBELLA CARD TEST (June 20, 1980)

FDA data resources