LEGIONELLA STAT IGG/IGM TEST KIT— 510(k) K911356

Name: FDA 510(k) clearance K911356
Creator: U.S. Food and Drug Administration
Published: 1992-07-30

Substantially Equivalent

Whittaker Bioproducts, Inc.

FDA 510(k) clearance K911356 for LEGIONELLA STAT IGG/IGM TEST KIT, Substantially Equivalent on 1992-07-30. Applicant: Whittaker Bioproducts, Inc.. Device class: 2.

Clearance details

Applicant: Whittaker Bioproducts, Inc.
Product code: Code MJH
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 1991-03-28
Decision date: 1992-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

Download summary PDF View on FDA.gov ↗

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