RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION— 510(k) K884192

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K884192 for RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION, Substantially Equivalent on 1988-11-22. Applicant: Baxter Diagnostics, Inc..

Clearance details

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

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