MYCOAKT M KANSASII CULTURE ID KIT— 510(k) K943050

Name: FDA 510(k) clearance K943050
Creator: U.S. Food and Drug Administration
Published: 1995-03-13

Substantially Equivalent

Dynagen, Inc.

FDA 510(k) clearance K943050 for MYCOAKT M KANSASII CULTURE ID KIT, Substantially Equivalent on 1995-03-13. Applicant: Dynagen, Inc.. Device class: 1.

Clearance details

Applicant: Dynagen, Inc.
Product code: Code JSY
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1994-06-27
Decision date: 1995-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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