BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST— 510(k) K991074

Substantially Equivalent

Intracel Corp.

FDA 510(k) clearance K991074 for BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST, Substantially Equivalent on 1999-12-21. Applicant: Intracel Corp..

Clearance details

Applicant: Intracel Corp.
Product code: Code MJH
Advisory panel: Microbiology
Date received: 1999-03-31
Decision date: 1999-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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