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135 0. 101 CV b. Linearity/assay reportable range Referred to k071041 c. Traceability Stability Expected values controls calibrators or methods d. Regulation section 21 CFR 864. 7750 - Prothrombin Time Test 2. Classification Class II 3. Product code GJS - Prothrombin Time Test 4. Substantial Equivalence Information Predicate device name s Predicate 510 k number s k071041 Comparison with predicate Measuring Range Sample Volume Reagent Similarities Device Patient Self-Testing measures...
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