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510(k) K863877

BENZODIAZEPINE ENZYME IMMUNOASSAY KIT by General Diagnostics — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1987
Date Received
October 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

Other clearances by General Diagnostics

  • K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT (September 19, 1988)
  • K872882 — CANNABINOID ENZYME IMMUNOASSAY KIT (November 3, 1987)
  • K871305 — COCAINE METABOLITE ENZYME IMMUNOASSAY KIT (June 5, 1987)
  • K864993 — QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE (March 31, 1987)
  • K842307 — GENERAL DIAG. CEFONICID 30MCG ANTIMIC (July 20, 1984)
  • K841465 — GENERAL DIAGNOSTICS PLATELET ANTIBODY (July 2, 1984)
  • K833709 — CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK (December 30, 1983)
  • K832653 — CEFUROXIME 30MCG. SUSCEP DISK (October 14, 1983)
  • K831179 — CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP (May 9, 1983)
  • K830731 — NETILMICIN 30 MCG ANTIMICROBIAL DISK (April 8, 1983)

Other clearances for product code JXM

  • K243498 — Alinity c Benzodiazepines Reagent Kit (December 11, 2024)
  • K221765 — ONLINE DAT Benzodiazepines II (December 23, 2022)
  • K190968 — CEDIA Benzodiazepine Assay (December 9, 2019)
  • K173963 — DRI Benzodiazepine Assay (February 21, 2018)
  • K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair (September 15, 2017)
  • K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (August 2, 2017)
  • K153597 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 23, 2016)
  • K151771 — Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (January 5, 2016)
  • K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (August 13, 2015)
  • K150356 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 13, 2015)