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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K943691
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IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx Folate Mo... 3 07/20/2004 FEI # 1415939
Abbott Laboratories HPD/ADD/GPRD
IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate Medium Con... 3 07/20/2004 FEI # 1415939
Abbott Laboratories HPD/ADD/GPRD
IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 1... 3 07/20/2004 FEI # 1415939
Abbott Laboratories HPD/ADD/GPRD
IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with human albumin;... 3 07/20/2004 FEI # 1415939
Abbott Laboratories HPD/ADD/GPRD
IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells... 2 01/06/2004 FEI # 1415939
Abbott Laboratories HPD/ADD/GPRD
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