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510(k) K240800

Access Intrinsic Factor Ab by Beckman Coulter, Inc. — Product Code LIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2024
Date Received
March 25, 2024
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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Other clearances for product code LIG

  • 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)
  • K903218 — IMX B12 (August 23, 1990)
  • K811927 — 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY (April 1, 1982)