KULTSURE STARSWAB (M210), MODIFICATION— 510(k) K943498

Name: FDA 510(k) clearance K943498
Creator: U.S. Food and Drug Administration
Published: 1994-11-30

Substantially Equivalent

Ncs Diagnostics, Inc.

FDA 510(k) clearance K943498 for KULTSURE STARSWAB (M210), MODIFICATION, Substantially Equivalent on 1994-11-30. Applicant: Ncs Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Ncs Diagnostics, Inc.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 1994-06-13
Decision date: 1994-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Etobicoke, Ontario, CA

Download summary PDF View on FDA.gov ↗

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