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510(k) K053422

RAPIDONE-COCAINE-150 TEST by American Bio Medica Corp. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2006
Date Received
December 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

Other clearances by American Bio Medica Corp.

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  • K073078 — RAPID TOX CUP (May 30, 2008)
  • K060760 — RAPIDONE-BUPRENORPHINE TEST (August 7, 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 DIO

  • K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (C (January 27, 2022)
  • K211973 — DRI Cocaine Metabolite Assay (September 24, 2021)
  • K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (March 12, 2020)
  • K181499 — DRI Cocaine Metabolite Assay (July 6, 2018)
  • K170293 — Emit II Plus Cocaine Metabolite Assay (October 25, 2017)
  • K163570 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (August 15, 2017)
  • K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (June 2, 2017)
  • K152232 — Quest Diagnostics HairCheck-DT (Cocaine) (November 18, 2016)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)