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510(k) K012907

LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL by Clinical Controls — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2001
Date Received
August 29, 2001
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 Clinical Controls

  • K964278 — WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTRO (November 22, 1996)
  • K962432 — LIQUISPEX URINE (MICRO)ALBUMIN CONTROL (July 5, 1996)
  • K955691 — SERUM VOLATILES CONTROL LEVEL 1 & 2 (April 24, 1996)
  • K955690 — AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 (April 24, 1996)
  • K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (August 24, 1995)
  • K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (May 2, 1995)
  • K946048 — LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 (February 10, 1995)
  • K946049 — LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 (February 10, 1995)
  • K946050 — LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 (February 10, 1995)
  • K946266 — FERRITIN CONTROL - LEVEL 1, 2, 3 (February 10, 1995)

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)