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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: LCP Applicant: BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVI Decision Date To: 04/02/2023
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variant ii turbo link hemoglobin a1c program, and variant ii turbo link hemoglobin testing with model, 270-2716, BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI K070819 06/25/2007
modification to variant ii: hemoglobin a1c program, beta-thalassemia short program and total ghb program BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI K063643 12/27/2006
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