510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K885344Substantially Equivalent

Immunocomb(tm) Toxoplasma Igg Antibody Test Kit

Orgenics, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885344 is the FDA 510(k) clearance record for IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT, a class II device, cleared for Orgenics, Ltd. on under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii). FDA records list 3 510(k) clearances for Orgenics, Ltd., from to . As of , FDA records show no recalls naming K885344.

Clearance record

Decision date
Received
(105 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
Orgenics, Ltd. 1120 Vermont Ave., NW, Washington DC
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