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Health / Medical equipment / Medical technology / Pharmacology / Hepatology / Medical device / Title 21 of the Code of Federal Regulations / Center for Devices and Radiological Health / Bilirubin / Medicine / Technology / Food and Drug Administration
Date: 2013-05-06 11:18:57
Health
Medical equipment
Medical technology
Pharmacology
Hepatology
Medical device
Title 21 of the Code of Federal Regulations
Center for Devices and Radiological Health
Bilirubin
Medicine
Technology
Food and Drug Administration

510(k) Summary Introduction According to the requirements of 21 CFR[removed], the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

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Source URL: www.accessdata.fda.gov

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