510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K885297Substantially Equivalent

Imx Rubella Igg, Microparticle Enzyme Immunoassay

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885297 is the FDA 510(k) clearance record for IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY, a class II device, cleared for Abbott Laboratories on under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K885297.

Clearance record

Decision date
Received
(178 days to decision)
Product code
LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review
No

Clearances, product code LFX

Trailing 12 months

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

FDA records show no clearances under product code LFX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFX, 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