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510(k) K003881

INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST by Alfa Scientific Designs, Inc. — Product Code JXM

K003881 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST". The FDA issued a decision of Substantially Equivalent on May 29, 2001. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2001
Date Received
December 15, 2000
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 Alfa Scientific Designs, Inc.

  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)
  • K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test (February 15, 2018)
  • K152122 — Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine (June 24, 2016)
  • K131645 — INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) (October 7, 2013)
  • K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI- (July 6, 2010)
  • K070660 — INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST (June 21, 2007)
  • K063545 — MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, (May 7, 2007)
  • K060527 — INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT (July 25, 2006)
  • K042227 — INSTANT-VIEW TROPONIN I TEST (November 19, 2004)
  • K024360 — INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST (June 10, 2003)

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