MULTIPLE (IZON DBS & URINE COLLECTION KIT)— 510(k) K950257

Name: FDA 510(k) clearance K950257
Creator: U.S. Food and Drug Administration
Published: 1995-04-14

Substantially Equivalent

Izon Business Products, Inc.

FDA 510(k) clearance K950257 for MULTIPLE (IZON DBS & URINE COLLECTION KIT), Substantially Equivalent on 1995-04-14. Applicant: Izon Business Products, Inc.. Device class: 1.

Clearance details

Applicant: Izon Business Products, Inc.
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1995-01-23
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Nyack, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXA

view all

K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)2001-11-30
K981084 — URISCREEN1998-10-07
K972676 — URINE SCREENING DEVICE1998-02-23
K952246 — TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT1995-06-20
K950221 — MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)1995-03-21

More clearances from Izon Business Products, Inc.

view all

K010328 — MULTIPLE (IZON DNA BLOOD COLLECTION KIT)2001-04-09
K950246 — MULTIPLE (IZON URINE COLLECTION KIT)1995-03-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.