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510(k) K021006

STARTOX DRUG OF ABUSE SCREENING TEST by Starplex Scientific, Inc. — Product Code DKZ

K021006 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "STARTOX DRUG OF ABUSE SCREENING TEST". The FDA issued a decision of Substantially Equivalent on June 10, 2002. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Starplex Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2002
Date Received
March 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Starplex Scientific, Inc.

  • K032246 — MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (August 13, 2003)
  • K022388 — STARTOX DRUG OF ABUSE SCREENING TEST (4) (February 27, 2003)
  • K962843 — MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (September 18, 1996)
  • K960997 — STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (April 3, 1996)
  • K944847 — KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (February 16, 1995)
  • K924364 — VACUPLUS TUBES WITH GREY STOPPERS (March 1, 1993)
  • K924361 — VACUPLUS TUBES WITH GREEN STOPPERS (March 1, 1993)
  • K924362 — VACUPLUS TUBES WITH LAVANDER STOPPERS (March 1, 1993)
  • K924363 — VACUPLUS(R) STAR-SEP(TM) (February 8, 1993)
  • K924365 — VACUPLUS TUBES WITH BRICK RED STOPPERS (December 28, 1992)

Other clearances for product code DKZ

  • K240670 — DRI Ecstasy Plus Assay (October 30, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (May 19, 2023)
  • K200363 — Quidel Triage® TOX Drug Screen, 94600 (March 11, 2020)
  • K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (October 3, 2019)
  • K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (June 19, 2019)
  • K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul (March 27, 2019)
  • K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- (December 14, 2018)
  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)

FDA data resources