RANDOX ALDOLASE CALIBRATION SERUM— 510(k) K142181

Name: FDA 510(k) clearance K142181
Creator: U.S. Food and Drug Administration
Published: 2014-09-18

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K142181 for RANDOX ALDOLASE CALIBRATION SERUM, Substantially Equivalent on 2014-09-18. Applicant: Randox Laboratories Limited. Device class: 2.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2014-08-08
Decision date: 2014-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIT

view all

K171168 — VITROS Immunodiagnostic Products Insulin Calibrators2017-05-16
K170938 — CalSet IGF-12017-04-26
K170160 — Abbott ARCHITECT Free T32017-02-15
K163534 — Lumipulse G FSH-N Calibrators2017-01-13
K163546 — Lumipulse G Progesterone-N Calibrators2017-01-13

More clearances from Randox Laboratories Limited

view all

K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT2023-10-05
K221550 — Evidence MultiSTAT DOA Urine MultiPlex2023-10-05
K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP)2017-04-21
K161691 — Direct LDL Cholesterol (LDL)2017-03-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.