OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)— 510(k) K011043

Name: FDA 510(k) clearance K011043
Creator: U.S. Food and Drug Administration
Published: 2001-11-30

Substantially Equivalent

Osmetech

FDA 510(k) clearance K011043 for OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI), Substantially Equivalent on 2001-11-30. Applicant: Osmetech. Device class: 1.

Clearance details

Applicant: Osmetech
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2001-04-05
Decision date: 2001-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crewe, GB

Download summary PDF View on FDA.gov ↗

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K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT)1995-04-14
K950221 — MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)1995-03-21

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