510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942458Substantially Equivalent

Precision-Multi-Sera - Human - Normal and Elevated

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

K942458 is the FDA 510(k) clearance record for PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED, a class I device, cleared for Randox Laboratories, Ltd. on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list 134 510(k) clearances for Randox Laboratories, Ltd., from to . As of , FDA records show 3 recalls naming K942458.

Clearance record

Decision date
Received
(293 days to decision)
Product code
JJY Multi-Analyte Controls, All Kinds (Assayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Randox Laboratories, Ltd. Ardmore, Diamond Rd., Crumlin, IE
510(k) summary
Statement
Third party review
No

Clearances, product code JJY

Trailing 12 months

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

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