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

Name: FDA 510(k) clearance K884191
Creator: U.S. Food and Drug Administration
Published: 1988-11-22

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.. Device class: 1.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code GNX
Device class: Class 1
Regulation: 21 CFR 866.3330
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 ↗

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