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510(k) K954968

HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST by Tcpi, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1996
Date Received
October 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
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)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • K955353 — ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT (March 19, 1996)
  • K952096 — ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) (August 17, 1995)
  • 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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