510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K021897Substantially Equivalent

Randox Haemoglobin A1c

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

K021897 is the FDA 510(k) clearance record for RANDOX HAEMOGLOBIN A1C, a class II device, cleared for Randox Laboratories, Ltd. on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show one recall naming K021897.

Clearance record

Decision date
Received
(169 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Randox Laboratories, Ltd. Ardmore, Diamond Rd., Crumlin, IE
510(k) summary
Statement
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

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