Home / 510(k) Clearances / K821135

510(k) K821135

PREALBUMIN ENZYME IMMUNOASSAY by Abbott Laboratories — Product Code JZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1983
Date Received
April 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prealbumin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5060
Review Panel
IM
Submission Type

Other clearances by Abbott Laboratories

  • 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)
  • K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT (May 19, 2023)

Other clearances for product code JZJ

  • K000661 — RANDOX PREALBUMIN (April 13, 2000)
  • K972638 — TINA-QUANT PREALBUMIN (January 9, 1998)
  • K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (June 1, 1995)
  • K913672 — PREALBUMIN IMMUNOLOGICAL NL TEST KIT (December 20, 1991)
  • K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMIN (November 2, 1988)
  • K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (November 2, 1988)
  • K883002 — QM300 PREALBUMIN ANTIBODY PACK (September 22, 1988)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K851912 — LASER PREALBUMIN TEST (June 21, 1985)
  • K772329 — LAS-R HUMAN PREALBUMIN TEST (February 3, 1978)