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510(k) K990873

DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE by Ameritek, Inc. — Product Code JMT

K990873 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE". The FDA issued a decision of Substantially Equivalent on September 1, 1999. The device falls under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)), a Class I device regulated under 21 CFR 862.1510. Ameritek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1999
Date Received
March 16, 1999
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 Ameritek, Inc.

  • K001215 — DBEST HCG 2 IU/ML TEST KIT (June 22, 2000)
  • K990681 — DBSET MULTIDRUG SCREEN TEST KIT (July 15, 1999)
  • K984269 — DBEST OCCULT BLOOD TEST KIT (May 11, 1999)
  • K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT (November 18, 1998)
  • K983190 — DBEST OPIATES TEST KIT (November 18, 1998)
  • K983191 — DBEST COCAINE TEST KIT (November 18, 1998)
  • K983189 — DBEST METHAMPHETAMINES TEST KIT (November 18, 1998)
  • K981504 — DBEST AMPHETAMINES TEST KIT (August 6, 1998)
  • K974508 — DBEST ONE-STEP OVULATION TEST (February 2, 1998)
  • K973957 — DBEST ONE-STEP HCG SERUM/URINE TEST (December 17, 1997)

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)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • 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)

FDA data resources