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510(k) K952096

ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) by Tcpi, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1995
Date Received
May 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Tcpi, Inc.

  • K981363 — ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST (December 22, 1998)
  • K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE (October 7, 1998)
  • K981197 — ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST (June 16, 1998)
  • K980776 — ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST (April 29, 1998)
  • K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (August 20, 1996)
  • K954968 — HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST (July 26, 1996)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • K955353 — ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT (March 19, 1996)
  • K951892 — ONE STEP URINE DRUG OF ABUSE COCAINE TEST (August 17, 1995)
  • K941765 — HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE (October 20, 1994)

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