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U.S. Department of Health and Human Services

Product Classification

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Device reader, zone, automated
Regulation Description Automated zone reader.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeKZK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.2850
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons