URISCREEN— 510(k) K882211

Substantially Equivalent

Diatech Diagnostica , Ltd.

FDA 510(k) clearance K882211 for URISCREEN, Substantially Equivalent on 1988-09-30. Applicant: Diatech Diagnostica , Ltd.. Device class: 1.

Clearance details

Applicant: Diatech Diagnostica , Ltd.
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1988-05-26
Decision date: 1988-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT)1995-04-14

More clearances from Diatech Diagnostica , Ltd.

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K882596 — MP TEST1989-06-21

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