HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG— 510(k) K003686

Name: FDA 510(k) clearance K003686
Creator: U.S. Food and Drug Administration
Published: 2001-01-12

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K003686 for HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG, Substantially Equivalent on 2001-01-12. Applicant: Hardy Diagnostics. Device class: 2.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 2000-11-30
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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