INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION— 510(k) K884191

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K884191 for INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION, Substantially Equivalent on 1988-11-22. Applicant: Baxter Diagnostics, Inc..

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code GNX
Advisory panel: Microbiology
Date received: 1988-10-06
Decision date: 1988-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.