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Product Classification Database

Devicesystem, blood culturing
Regulation DescriptionMicrobial growth monitor.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeMDB
Submission Type 510(k)
Regulation Number 866.2560
Device Class 1
GMP Exempt? No
Guidance Document

  • Review Criteria for Blood Culture Systems [http://www.fda.gov/cdrh/ode/82.pdf] 
Third Party Review
Accredited Persons

Database Updated 02/06/2009

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