PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS— 510(k) K862743

Name: FDA 510(k) clearance K862743
Creator: U.S. Food and Drug Administration
Published: 1986-09-29

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K862743 for PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS, Substantially Equivalent on 1986-09-29. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1986-07-21
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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