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510(k) K984108

ABBOTT ARCHITECT B12 by Abbott Laboratories — Product Code LIG

K984108 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT ARCHITECT B12". The FDA issued a decision of Substantially Equivalent on February 3, 1999. 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
February 3, 1999
Date Received
November 17, 1998
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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  • 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)
  • K903218 — IMX B12 (August 23, 1990)
  • K811927 — 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY (April 1, 1982)

FDA data resources