Home / 510(k) Clearances / K130650

510(k) K130650

STATUS DS OXY by Princeton BioMeditech Corp. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2014
Date Received
March 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
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)
  • 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)
  • K062575 — MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP (November 26, 2007)

Other clearances for product code DJG

  • K252684 — Labcorp Fentanyl Urine Visual Test (January 29, 2026)
  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K253082 — LZI Buprenorphine II Enzyme Immunoassay (January 16, 2026)
  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 2025)
  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K240124 — BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (June 14, 2024)
  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
  • K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (March 8, 2024)
  • K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug (February 23, 2024)