BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT— 510(k) K003204

Substantially Equivalent

Intracel Corp.

FDA 510(k) clearance K003204 for BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT, Substantially Equivalent on 2000-11-07. Applicant: Intracel Corp.. Device class: 1.

Clearance details

Applicant
Intracel Corp.
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
Special
Location
Rockville, MD, US
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