WELLCOZYME HSV WZO2— 510(k) K875311

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K875311 for WELLCOZYME HSV WZO2, Substantially Equivalent on 1988-08-03. Applicant: Wellcome Diagnostics. Device class: 2.

Clearance details

Applicant
Wellcome Diagnostics
Product code
Code GQN
Device class
Class 2
Regulation
21 CFR 866.3305
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Research Triangle Pk, NC, US
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