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510(k) K950383

APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT by Randox Laboratories, Ltd. — Product Code JHN

K950383 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code JHN (Turbidimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
January 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric Method, Lipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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  • 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 JHN

  • K950382 — APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT (September 15, 1995)
  • K952615 — WAKO AUTOKIT APO A1 (September 8, 1995)
  • K952425 — OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT (July 5, 1995)
  • K952466 — OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT (June 5, 1995)
  • K932606 — APOLIPOPROTIEN A-1 (APO A-1) (June 2, 1994)
  • K932603 — APOLIPOPROTIEN B (APO B) (June 2, 1994)

FDA data resources