Home / 510(k) Clearances / K980776

510(k) K980776

ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST by Tcpi, Inc. — Product Code JXM

K980776 is an FDA 510(k) premarket notification submitted by Tcpi, Inc. for the device "ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST". The FDA issued a decision of Substantially Equivalent on April 29, 1998. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Tcpi, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1998
Date Received
March 2, 1998
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 Tcpi, Inc.

  • K981363 — ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST (December 22, 1998)
  • K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE (October 7, 1998)
  • K981197 — ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST (June 16, 1998)
  • K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (August 20, 1996)
  • K954968 — HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST (July 26, 1996)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • K955353 — ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT (March 19, 1996)
  • K951892 — ONE STEP URINE DRUG OF ABUSE COCAINE TEST (August 17, 1995)
  • K952096 — ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) (August 17, 1995)
  • K941765 — HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE (October 20, 1994)

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)

FDA data resources