Home / 510(k) Clearances / K953211

510(k) K953211

AMYLASE (ETHYLIDENE PNGPG7) KIT by Randox Laboratories, Ltd. — Product Code CIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1996
Date Received
July 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saccharogenic, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

Other clearances by Randox Laboratories, Ltd.

  • DEN240035 — ConcizuTrace™ ELISA (May 22, 2025)
  • K230890 — ISE Electrodes (September 8, 2023)
  • K182042 — Randox Calcium (Ca) (October 23, 2018)
  • K162200 — Randox RX Daytona Plus Magnesium (MG) (April 28, 2017)
  • K152085 — Liquid CO2-2 (LCO2-2) (February 24, 2016)
  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • K150654 — Cholesterol (September 29, 2015)
  • K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE ( (January 9, 2014)
  • K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (November 21, 2013)
  • K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3 (October 23, 2013)

Other clearances for product code CIJ

  • K023396 — AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (December 23, 2002)
  • K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (July 22, 1999)
  • K980013 — AMYLASE (February 4, 1998)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (December 11, 1995)
  • K940735 — LIQUID AMYLASE (CNPG3) REAGENT SET (August 1, 1994)
  • K940010 — DMA AMYLASE (DEMAND) PROCEDURE (March 11, 1994)
  • K931301 — OLYMPUS AMYLASE REAGENT (October 18, 1993)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • K882225 — -AMYLASE EPS (January 3, 1989)
  • K873572 — IL 35260, IL TEST AMYLASE REAGENT (October 20, 1987)