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U.S. Department of Health and Human Services

Product Classification
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Device atp release (luminescence)
Regulation Description Adenosine triphosphate release assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJWR
Submission Type 510(k)
Regulation Number 864.7040
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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