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510(k) K903218

IMX B12 by Abbott Laboratories — Product Code LIG

K903218 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "IMX B12". The FDA issued a decision of Substantially Equivalent on August 23, 1990. The device falls under product code LIG (Radioassay, Intrinsic Factor Blocking Antibody), a Class II device regulated under 21 CFR 862.1810. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1990
Date Received
July 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Intrinsic Factor Blocking Antibody
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

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  • 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 LIG

  • K240800 — Access Intrinsic Factor Ab (May 3, 2024)
  • K071346 — IMMULISA INTRINSIC FACTOR ANTIBODY ELISA (September 24, 2007)
  • K061841 — QUANTA LITE INTRINSIC FACTOR ELISA (December 22, 2006)
  • K033603 — INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MOD (December 19, 2003)
  • K993251 — IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 (November 17, 1999)
  • K984108 — ABBOTT ARCHITECT B12 (February 3, 1999)
  • K811927 — 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY (April 1, 1982)

FDA data resources