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510(k) K192299

LZI Cotinine II Enzyme Immunoassay by Lin-Zhi International, Inc. — Product Code MKU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2019
Date Received
August 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

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Other clearances for product code MKU

  • K192517 — Psychemedics Microplate EIA for Cotinine in Hair (April 22, 2020)
  • K062565 — STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (February 20, 2007)
  • K021944 — COZART EIA COTININE URINE KIT (May 14, 2003)
  • K974534 — MICRO-PLATE COTININE EIA (May 18, 1998)
  • K974234 — MICRO-PLATE COTININE EIA (May 14, 1998)
  • K972481 — AUTO-LYTE COTININE EIA (October 21, 1997)