510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801019Substantially Equivalent

125I-Ige Radioimmunoassay Kit

Bio-Ria, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801019 is the FDA 510(k) clearance record for 125I-IGE RADIOIMMUNOASSAY KIT, a class II device, cleared for Bio-Ria on under FDA product code DGC (Ige, Antigen, Antiserum, Control). FDA records list 2 510(k) clearances for Bio-Ria, from to . As of , FDA records show no recalls naming K801019.

Clearance record

Decision date
Received
(20 days to decision)
Product code
DGC Ige, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Bio-Ria 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DGC

Trailing 12 months

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

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