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510(k) K031497

AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST by Amedica Biotech, Inc. — Product Code DJC

K031497 is an FDA 510(k) premarket notification submitted by Amedica Biotech, Inc. for the device "AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST". The FDA issued a decision of Substantially Equivalent on October 17, 2003. The device falls under product code DJC (Thin Layer Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Amedica Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2003
Date Received
May 13, 2003
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 Amedica Biotech, Inc.

  • K100108 — AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA (April 14, 2010)
  • K082898 — AMEDICA DRUG SCREEN TEST CUP (December 19, 2008)
  • K080872 — AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ (August 19, 2008)
  • K063379 — AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C121 (December 11, 2006)
  • K061556 — AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1 (July 21, 2006)
  • K040464 — AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST (May 17, 2004)
  • K023109 — AMEDICA DRUG SCREEN PHENCYCLIDINE TEST (December 16, 2002)
  • K023101 — AMEDICA DRUG SCREEN METHAPHETAMINE TEST (December 16, 2002)
  • K023104 — AMEDICA DRUG SCREEN AMPHETAMINE TEST (December 16, 2002)
  • K022954 — AMEDICA DRUG SCREEN COCAINE TEST (November 6, 2002)

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