Home / 510(k) Clearances / K960888

510(k) K960888

CHEK-STIX U.T.I. SELF-TEST by Bayer Corp. — Product Code JMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1996
Date Received
March 4, 1996
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 Bayer Corp.

  • K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER (March 3, 2003)
  • K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (February 11, 2003)
  • K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY (January 30, 2003)
  • K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (January 23, 2003)
  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
  • K023584 — ASCENSIA DEX 2 DIABETES CARE SYSTEM (November 20, 2002)
  • K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (July 24, 2002)
  • K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (July 5, 2002)
  • K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)

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)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • K953672 — FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (July 1, 1996)
  • K875248 — BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS (February 24, 1988)