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510(k) K073078

RAPID TOX CUP by American Bio Medica Corp. — Product Code LAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2008
Date Received
October 31, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Pressure Liquid Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by American Bio Medica Corp.

  • K170222 — Rapid Tox Cup II (August 15, 2017)
  • K060760 — RAPIDONE-BUPRENORPHINE TEST (August 7, 2006)
  • K053422 — RAPIDONE-COCAINE-150 TEST (June 15, 2006)
  • K053359 — RAPIDTOX (May 25, 2006)
  • K041696 — RAPID READER (July 12, 2005)
  • K041712 — 'RAPIDTEC 4' TEST (November 3, 2004)
  • K030835 — 'RAPID ONE' - PROPOXYPHENE TEST (May 22, 2003)
  • K023869 — 'RAPIDTEC'-5M-MULTIPLE DIP TEST (April 30, 2003)
  • K021114 — 'RAPIDTEC' 5A MULTIPLE DIP TEST (July 23, 2002)
  • K014101 — RAPIDONE-OXY TEST (March 20, 2002)

Other clearances for product code LAG

  • K062575 — MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP (November 26, 2007)
  • K990786 — ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/ (March 26, 1999)
  • K983501 — ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/ (December 18, 1998)