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510(k) K973448

ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 by Beckman Instruments, Inc. — Product Code LGD

K973448 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469". The FDA issued a decision of Substantially Equivalent on September 17, 1998. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1998
Date Received
September 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Beckman Instruments, Inc.

  • K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (July 14, 1998)
  • K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (May 8, 1998)
  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
  • K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (March 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (February 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (December 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (December 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (December 15, 1997)
  • K973928 — BECKMAN URINE PROTEIN CALIBRATOR (UCAL) (December 1, 1997)

Other clearances for product code LGD

  • K242022 — Access Toxo IgG (March 28, 2025)
  • K242095 — Access Toxo IgM II (October 11, 2024)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K210596 — ARCHITECT Toxo IgG (May 19, 2022)
  • K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (June 23, 2017)
  • K142826 — ADVIA Centaur Toxoplasma M (Toxo M) (December 22, 2015)
  • K132234 — LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (August 28, 2013)
  • K131441 — LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (August 9, 2013)
  • K101946 — VIDAS TOXO IGG AVIDITY (May 18, 2011)
  • K102681 — ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (May 4, 2011)

FDA data resources