Home / 510(k) Clearances / K151557

510(k) K151557

EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine by Nantong Egens Biotech Co., Ltd. — Product Code DNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2015
Date Received
June 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Morphine
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type

Other clearances by Nantong Egens Biotech Co., Ltd.

  • K152643 — EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Te (November 2, 2015)

Other clearances for product code DNK

  • K150602 — CR3 Keyless Split Sample Cup Morphine - Methamphetamine (April 7, 2015)
  • K970579 — ONE STEP MORPHINE CARD TEST (July 3, 1997)
  • K853140 — MDI QUIK TEST NARCOTICS DRUG SCREEN (March 3, 1986)