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Product Classification Database

Deviceelectrophoretic separation, alkaline phosphatase isoenzymes
Regulation DescriptionAlkaline phosphatase or isoenzymes test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeCIN
Submission Type 510(k)
Regulation Number 862.1050
Device Class 2
GMP Exempt? No
Third Party Review
Accredited Persons

Database Updated 02/06/2009

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