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New Search Back To Search Results Device reader, zone, automated Regulation Description Automated zone reader. Regulation Medical Specialty Microbiology Review Panel Microbiology Product Code KZK Submission Type 510(k) Regulation Number 866.2850 Device Class 1 GMP Exempt? No Third Party Review Eligible for Accredited Persons Program Accredited Persons british standards institution center for measurement standards of industrial cheiroon bv citech intertek testing services regulatory technology services, llc tuv rheinland of north america, inc. tuv sud america inc. underwriters laboratories, inc.