Home / 510(k) Clearances / K983289

510(k) K983289

APOLIPOPROTEIN A1 by Abbott Laboratories — Product Code DER

K983289 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "APOLIPOPROTEIN A1". The FDA issued a decision of Substantially Equivalent on January 29, 1999. The device falls under product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5580. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1999
Date Received
September 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5580
Review Panel
IM
Submission Type

Other clearances by Abbott Laboratories

  • K252424 — Anti-HCV Next (April 28, 2026)
  • 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 DER

  • K013249 — TINA-QUANT APOLIPOPROTEIN VER.2 (November 16, 2001)
  • K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3 (May 18, 2000)
  • K993354 — K-ASSAY APO B (October 28, 1999)
  • K993345 — K-ASSAY APO AI (October 25, 1999)
  • K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (April 14, 1999)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K910553 — ROCHE APOLIPOPROTEIN STANDARD (May 8, 1991)
  • K904125 — UC IMU A (September 24, 1990)

FDA data resources