510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955798Substantially Equivalent

Igg Immunoturbidimetric & Calibrator

Randox Laboratories, Limited, Crumlin, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955798 is the FDA 510(k) clearance record for IGG IMMUNOTURBIDIMETRIC & CALIBRATOR, a class II device, cleared for Randox Laboratories, Ltd. on under FDA product code DEW (Igg, Antigen, Antiserum, Control). FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show no recalls naming K955798.

Clearance record

Decision date
Received
(105 days to decision)
Product code
DEW Igg, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Randox Laboratories, Ltd. Ardmore, Diamond Rd., Crumlin, IE
510(k) summary
Statement
Third party review
No

Clearances, product code DEW

Trailing 12 months

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

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