510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090847Substantially Equivalent

Platelia Toxo Igm Kit Model 26211

Bio-Rad Laboratories Inc., Redmond WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K090847 is the FDA 510(k) clearance record for PLATELIA TOXO IGM KIT MODEL 26211, a class II device, cleared for Bio-Rad Laboratories on under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from to . As of , FDA records show one recall naming K090847.

Clearance record

Decision date
Received
(93 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
Bio-Rad Laboratories 6565 185th Ave., NE, Redmond WA
510(k) summary
Statement
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LGD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260