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510(k) K052197

FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST by W.H.P.M., Inc. — Product Code DJR

K052197 is an FDA 510(k) premarket notification submitted by W.H.P.M., Inc. for the device "FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST". The FDA issued a decision of Substantially Equivalent on June 9, 2006. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. W.H.P.M., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2006
Date Received
August 12, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methadone
Device Class
Class II
Regulation Number
862.3620
Review Panel
TX
Submission Type

Other clearances by W.H.P.M., Inc.

  • K200754 — Hemosure Accu-Reader A100 (June 2, 2022)
  • K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign (August 12, 2021)
  • K171695 — First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign (February 5, 2018)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152551 — First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Bupr (November 9, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 2015)
  • K142353 — First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (October 7, 2014)
  • K051841 — WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST (August 22, 2005)
  • K041202 — HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST (August 12, 2004)

Other clearances for product code DJR

  • K192433 — LZI Methadone II Enzyme Immunoassay (October 4, 2019)
  • K182779 — ARK EDDP Assay (November 21, 2018)
  • K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 3 (June 26, 2017)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152025 — AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (October 5, 2015)
  • K151395 — Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calib (July 24, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K131232 — WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (May 31, 2013)
  • K092272 — RANDOX METHADONE ASSAY (November 18, 2010)
  • K092258 — RANDOX METABOLITE (EDDP) ASSAY (November 9, 2010)

FDA data resources