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510(k) K910123

TARGET COCAINE METABOLITE-V by V-Tech, Inc. — Product Code KLN

K910123 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "TARGET COCAINE METABOLITE-V". The FDA issued a decision of Substantially Equivalent on March 19, 1991. The device falls under product code KLN (Radioimmunoassay, Cocaine Metabolite), a Class II device regulated under 21 CFR 862.3250. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1991
Date Received
January 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cocaine Metabolite
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

Other clearances by V-Tech, Inc.

  • K914303 — TARGET(TM)-HOG (October 11, 1991)
  • K910892 — TARGET(TM) CANNABINOIDS-V TEST (April 3, 1991)
  • K910893 — TARGET(TM) CANNABINOIDS-R TEST (April 3, 1991)
  • K910739 — TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) (March 21, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K910738 — TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) (March 19, 1991)
  • K903937 — TARGET(TM) HOG ONE STEP (October 22, 1990)
  • K890978 — TARGET OPIATES-R (November 17, 1989)
  • K890979 — TARGET OPIATES-V (October 4, 1989)
  • K890295 — TARGET(TM) CK-MB (August 15, 1989)

Other clearances for product code KLN

  • K010868 — PSYCHEMEDICS RIA COCAINE ASSAY (November 6, 2001)
  • K913867 — URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (September 19, 1991)
  • K913722 — ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE (September 10, 1991)
  • K912756 — ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (July 26, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K910044 — MILENIA COCAINE METABOLITE (February 13, 1991)
  • K905730 — ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (January 15, 1991)
  • K904995 — ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (November 28, 1990)
  • K880674 — MICROMEDIC CRACKPOT RIA KIT (October 6, 1988)
  • K871549 — RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (June 16, 1987)

FDA data resources