Home / 510(k) Clearances / K033603

510(k) K033603

INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 by Beckman Coulter, Inc. — Product Code LIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
November 17, 2003
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

Other clearances by Beckman Coulter, Inc.

  • K254059 — Access anti-HBc IgM (March 13, 2026)
  • K253687 — Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access (February 19, 2026)
  • K251995 — Access anti-HAV IgM (January 27, 2026)
  • K250588 — Access Rubella IgG (November 17, 2025)
  • K252580 — iQ200 Series (September 10, 2025)
  • K243846 — Access anti-HAV (September 9, 2025)
  • K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/m (August 20, 2025)
  • K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg (August 15, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/m (July 18, 2025)

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)
  • 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)