510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080869Substantially Equivalent

Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg Qc

Siemens Healthcare Diagnostics Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080869 is the FDA 510(k) clearance record for ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K080869.

Clearance record

Decision date
Received
(53 days to decision)
Product code
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Beckman Coulter, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LGD

Trailing 12 months

FDA records hold no clearances under product code LGD in the trailing twelve months.

FDA records show no clearances under product code LGD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LGD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260