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510(k) K952412

DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL by Dupont Medical Products — Product Code DIF

K952412 is an FDA 510(k) premarket notification submitted by Dupont Medical Products for the device "DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL". The FDA issued a decision of Substantially Equivalent on June 23, 1995. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Dupont Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1995
Date Received
May 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Dupont Medical Products

  • K952815 — DUPONT LIPASE CALIBRATOR (August 31, 1995)
  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (August 11, 1995)
  • K952816 — LIPASE FLEX REAGENT CARTRIDGE (July 20, 1995)
  • K945280 — DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (March 9, 1995)
  • K944932 — PHENOBARBITAL FLEX REAGENT CARTRIDGE (December 28, 1994)
  • K941050 — DUPONT ACA STAR (November 10, 1994)
  • K943996 — DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (October 20, 1994)
  • K941146 — DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM (October 3, 1994)
  • K942640 — DUPONT DIMENSION AMYLASE METHOD (September 9, 1994)
  • K942241 — DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN (August 18, 1994)

Other clearances for product code DIF

  • K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, (February 23, 2016)
  • K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/N (December 16, 2013)
  • K132174 — MULTICHEM WBT (September 20, 2013)
  • K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (July 3, 2012)
  • K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (May 18, 2012)
  • K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOG (March 27, 2012)
  • K103656 — THERMO SCIENTIFIC MAS R DOA TOTAL (March 24, 2011)
  • K093577 — LIQUICHEK OPIATE CONTROL (March 12, 2010)
  • K080085 — MAS TOX CONTROL (April 30, 2008)
  • K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMI (March 25, 2008)

FDA data resources