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510(k) K100051

INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) by Alfa Scientific Designs, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2010
Date Received
January 8, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
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)
  • 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)
  • K022693 — INSTANT-VIEW TCA URINE TEST (December 9, 2002)

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