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510(k) K023101

AMEDICA DRUG SCREEN METHAPHETAMINE TEST by Amedica Biotech, Inc. — Product Code LAF

K023101 is an FDA 510(k) premarket notification submitted by Amedica Biotech, Inc. for the device "AMEDICA DRUG SCREEN METHAPHETAMINE TEST". The FDA issued a decision of Substantially Equivalent on December 16, 2002. The device falls under product code LAF (Gas 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
December 16, 2002
Date Received
September 18, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas 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)
  • K031497 — AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST (October 17, 2003)
  • K023109 — AMEDICA DRUG SCREEN PHENCYCLIDINE 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 LAF

  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (December 15, 2021)
  • K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus (July 31, 2020)
  • K170222 — Rapid Tox Cup II (August 15, 2017)
  • K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (March 18, 2016)
  • K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methampheta (September 18, 2015)
  • K150096 — Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclid (March 4, 2015)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 2015)
  • K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET (December 18, 2014)
  • K131652 — LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (March 21, 2014)

FDA data resources