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510(k) K022388

STARTOX DRUG OF ABUSE SCREENING TEST (4) by Starplex Scientific, Inc. — Product Code DJC

K022388 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "STARTOX DRUG OF ABUSE SCREENING TEST (4)". The FDA issued a decision of Substantially Equivalent on February 27, 2003. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Starplex Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2003
Date Received
July 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Starplex Scientific, Inc.

  • K032246 — MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (August 13, 2003)
  • K021006 — STARTOX DRUG OF ABUSE SCREENING TEST (June 10, 2002)
  • 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 DJC

  • K253705 — Healgen® Accurate Oral Fluid Drug Test (March 16, 2026)
  • K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube) (March 18, 2025)
  • K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxaze (December 17, 2018)
  • K181305 — OralTox Oral fluid Drug Test (September 20, 2018)
  • K171403 — OralTox Oral Fluid Drug Test (February 2, 2018)
  • K161044 — AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split (July 6, 2016)
  • K132630 — WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (ME (September 27, 2013)
  • K080347 — UNISCAN -DOA SYSTEM (October 9, 2008)
  • K060355 — ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 (August 7, 2006)
  • K060896 — MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT (June 9, 2006)

FDA data resources