AMYLASE (ETHYLIDENE PNGPG7) KIT— 510(k) K953211

Name: FDA 510(k) clearance K953211
Creator: U.S. Food and Drug Administration
Published: 1996-06-21

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K953211 for AMYLASE (ETHYLIDENE PNGPG7) KIT, Substantially Equivalent on 1996-06-21. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CIJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1995-07-10
Decision date: 1996-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIJ

view all

K023396 — AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)2002-12-23
K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM1999-07-22
K980013 — AMYLASE1998-02-04
K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)1995-12-11
K940735 — LIQUID AMYLASE (CNPG3) REAGENT SET1994-08-01

More clearances from Randox Laboratories, Ltd.

view all

DEN240035 — ConcizuTrace ELISA2025-05-22
K230890 — ISE Electrodes2023-09-08
K182042 — Randox Calcium (Ca)2018-10-23
K162200 — Randox RX Daytona Plus Magnesium (MG)2017-04-28
K152085 — Liquid CO2-2 (LCO2-2)2016-02-24

Recalls naming K953211

K-number listed on FDA's recall record

Z-2923-2020 — Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 ReagentClass II·Terminated·RANDOX LABORATORIES, LTD.·20200710

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K953211.

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