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510(k) K062575

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP by Princeton BioMeditech Corp. — Product Code LAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2007
Date Received
August 31, 2006
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

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Other clearances for product code LAG

  • K073078 — RAPID TOX CUP (May 30, 2008)
  • 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)