IMAGEN RESPIRATORY SCREEN— 510(k) K962037

Substantially Equivalent

Dako Diagnostics , Ltd.

FDA 510(k) clearance K962037 for IMAGEN RESPIRATORY SCREEN, Substantially Equivalent on 1996-12-26. Applicant: Dako Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant
Dako Diagnostics , Ltd.
Product code
Code GNW
Device class
Class 1
Regulation
21 CFR 866.3330
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cambridgeshire, GB
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