Home / 510(k) Clearances / K990786

510(k) K990786

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ by Princeton BioMeditech Corp. — Product Code LAG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1999
Date Received
March 10, 1999
Clearance Type
Special
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 Princeton BioMeditech Corp.

  • K251538 — Status™ COVID-19/Flu A&B (November 14, 2025)
  • K182157 — BioSign Flu A+B (September 18, 2018)
  • K130650 — STATUS DS OXY (February 26, 2014)
  • K133474 — BIOSIGN FLU A + B, STATUS FLU A & B (December 10, 2013)
  • K132465 — BIOSIGN FLU A + B, STATUS FLU A & B (September 9, 2013)
  • K083746 — BIOSIGN FLU A+B (November 10, 2010)
  • K100817 — BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (July 1, 2010)
  • K100341 — SPERMCHECK FERTILITY (May 4, 2010)
  • K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (October 6, 2008)
  • K073039 — SPERMCHECK VASECTOMY (January 24, 2008)

Other clearances for product code LAG

  • K073078 — RAPID TOX CUP (May 30, 2008)
  • K062575 — MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP (November 26, 2007)
  • K983501 — ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/ (December 18, 1998)