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I. Substantial Equivalence Information 1. Predicate device name s Bayer Clinitest hCG Pregnancy Test and Quidel QuickVue One-Step hCG-Combo 2. Predicate K number s k023944 k020801 3. Comparison with predicate The device and its predicates share the same intended use and basic assay principle. Applicant Bayer Healthcare LLC E. Proprietary and Established Names Clinitest hCG Pregnancy Test F. Regulatory Information 1. Negative urine samples spiked with hCG were tested on the Clinitek analyzer...
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