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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K012287
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Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche... 2 10/09/2008 FEI # 1823260
Roche Diagnostics Corp.
LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the q... 2 06/27/2015 FEI # 1823260
Roche Diagnostics Operations, Inc.
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