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510(k) K140665

GenPrime Snap-Top Split Key Cup by Genprime, Inc. — Product Code DIS

K140665 is an FDA 510(k) premarket notification submitted by Genprime, Inc. for the device "GenPrime Snap-Top Split Key Cup". The FDA issued a decision of Substantially Equivalent on December 8, 2014. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Genprime, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2014
Date Received
March 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Genprime, Inc.

  • K130082 — GENPRIME DRUGS OF ABUSE READER SYSTEM (December 20, 2013)

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)
  • 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)
  • K062165 — VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT (January 5, 2007)

FDA data resources