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510(k) K011303

RANDOX PHENOBARBITAL by Randox Laboratories, Ltd. — Product Code DLZ

K011303 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX PHENOBARBITAL". The FDA issued a decision of Substantially Equivalent on July 2, 2001. The device falls under product code DLZ (Enzyme Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2001
Date Received
April 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
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 DLZ

  • K210858 — VITROS Chemistry Products PHBR Slides (August 13, 2021)
  • K123271 — ABBOTT PHENOBARBITAL ASSAY (April 26, 2013)
  • K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODE (September 26, 2008)
  • K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 (September 12, 2007)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K000012 — IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 (March 3, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)
  • K984288 — VITROS CHEMISTRY PRODUCTS PHBR SLIDES (January 26, 1999)
  • K946210 — PHENOBARBITAL ENZYME IMMUNOASSAY (February 10, 1995)
  • K943981 — IL TEST PHENOBARBITAL CALIBRATORS (January 18, 1995)

FDA data resources