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510(k) K151557

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

K151557 is an FDA 510(k) premarket notification submitted by Nantong Egens Biotech Co., Ltd. for the device "EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine". The FDA issued a decision of Substantially Equivalent on July 16, 2015. The device falls under product code DNK (Thin Layer Chromatography, Morphine), a Class II device regulated under 21 CFR 862.3640. Nantong Egens Biotech Co., Ltd. has at least 1 other 510(k) clearance on record.

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)

FDA data resources