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U.S. Department of Health and Human Services

Product Classification

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Device antisera, fluorescent, chlamydia spp.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLKI
Submission Type 510(k)
Regulation Number 866.3120
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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