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510(k) K993850

URINALYSIS REAGENT STRIPS (10 PARAMETERS) by International Newtech Development, Inc. — Product Code JMT

K993850 is an FDA 510(k) premarket notification submitted by International Newtech Development, Inc. for the device "URINALYSIS REAGENT STRIPS (10 PARAMETERS)". The FDA issued a decision of Substantially Equivalent on January 3, 2000. The device falls under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)), a Class I device regulated under 21 CFR 862.1510. International Newtech Development, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2000
Date Received
November 12, 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 International Newtech Development, Inc.

  • K974059 — ONE STEP MIDSTREAM HCG PREGNANCY TEST (April 9, 1998)
  • K974060 — MINISTRIP/ SERUM AND URINE COMBO HCG TEST (April 9, 1998)
  • K974009 — PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG (March 13, 1998)
  • K970176 — HCG CONTROLS (February 6, 1997)
  • K963133 — PS-UNIT CASSETTE/SERUM HCG (November 18, 1996)
  • K963132 — MINI STRIP/SERUM HCG (November 18, 1996)
  • K951705 — MINISTRIP HCG (October 3, 1995)

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)
  • K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (September 1, 1999)
  • 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