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510(k) K012133

LIVESURE BARBITURATES SCREEN TEST by Pan Probe Biotech, Inc. — Product Code DIS

K012133 is an FDA 510(k) premarket notification submitted by Pan Probe Biotech, Inc. for the device "LIVESURE BARBITURATES SCREEN TEST". The FDA issued a decision of Substantially Equivalent on July 20, 2001. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Pan Probe Biotech, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2001
Date Received
July 9, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

Other clearances by Pan Probe Biotech, Inc.

  • K020968 — LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD (July 15, 2002)
  • K013796 — LIVESURE METHADONE SCREEN TESTS (November 26, 2001)
  • K012107 — LIVESURE PHENECYCLINE (PCP) SCREEN TESTS (July 20, 2001)
  • K012131 — LIVESURE BENZODIAZEPINES SCREEN TESTS (July 20, 2001)
  • K011610 — LIVESURE METHAMPHETAMINE SCREEN TESTS (June 8, 2001)
  • K011609 — LIVESURE AMPHETAMINE SCREEN TEST (June 8, 2001)
  • K010967 — LIVESURE COCAINE SCREEN TEST (April 17, 2001)
  • K011011 — LIVESURE MORPHINE SCREEN TEST (April 13, 2001)
  • K010001 — LIVESURE THC SCREEN TEST (February 5, 2001)

Other clearances for product code DIS

  • K161714 — Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibr (October 14, 2016)
  • K151211 — AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbit (June 4, 2015)
  • K150791 — Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphin (April 24, 2015)
  • K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone (January 13, 2015)
  • K140665 — GenPrime Snap-Top Split Key Cup (December 8, 2014)
  • K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (June 16, 2014)
  • K092268 — RANDOX BARITURATES ASSAY (May 25, 2011)
  • K110515 — UCP DRUG SCREENING TEST CUPS (April 20, 2011)
  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (December 7, 2007)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)

FDA data resources