HARDYDISK AZTREONAM, 30MCG— 510(k) K994063

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K994063 for HARDYDISK AZTREONAM, 30MCG, Substantially Equivalent on 2000-01-14. 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: 1999-12-01
Decision date: 2000-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.