LYFO(TM) DIFFERENTIAL DISK-BACITRACIN— 510(k) K970009

Name: FDA 510(k) clearance K970009
Creator: U.S. Food and Drug Administration
Published: 1997-02-06

Substantially Equivalent

Microbiologics, Inc.

FDA 510(k) clearance K970009 for LYFO(TM) DIFFERENTIAL DISK-BACITRACIN, Substantially Equivalent on 1997-02-06. Applicant: Microbiologics, Inc.. Device class: 1.

Clearance details

Applicant: Microbiologics, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1997-01-02
Decision date: 1997-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Cloud, MN, US

Download summary PDF View on FDA.gov ↗

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