URISCREEN— 510(k) K981084

Substantially Equivalent

Diatech Diagnostics,Inc.

FDA 510(k) clearance K981084 for URISCREEN, Substantially Equivalent on 1998-10-07. Applicant: Diatech Diagnostics,Inc..

Clearance details

Applicant
Diatech Diagnostics,Inc.
Product code
Code JXA
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beverly, MA, US
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