Home / 510(k) Clearances / K954685

510(k) K954685

URITEST - NITRITE IN URINE TEST by Tcpi, Inc. — Product Code JMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1996
Date Received
October 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Device Class
Class I
Regulation Number
862.1510
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)
  • K954968 — HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST (July 26, 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)

Other clearances for product code JMT

  • K251800 — Healgen® URS Test Strips (December 23, 2025)
  • K252607 — AllTest Urinary Tract Infection Test (October 30, 2025)
  • K242767 — Safecare Urinary Tract Infection Test (January 10, 2025)
  • K170118 — Scanostics UTI Check Application Test System (September 21, 2017)
  • K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS (February 17, 2011)
  • K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS) (January 3, 2000)
  • K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (September 1, 1999)
  • K960888 — CHEK-STIX U.T.I. SELF-TEST (July 5, 1996)
  • K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (July 1, 1996)
  • K875248 — BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS (February 24, 1988)