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Biosite Inc Dba Innovacon Inc.

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Chole recall (Z-2402-2011)Biosite Inc Dba Innovacon Inc.2011-06-01
SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A R recall (Z-1395-2011)Biosite Inc Dba Innovacon Inc.2011-02-22
Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712. Ass recall (Z-0439-2011)Biosite Inc Dba Innovacon Inc.2010-11-22
Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number 12-713. Ass recall (Z-0440-2011)Biosite Inc Dba Innovacon Inc.2010-11-22
Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982. Assayed qua recall (Z-0441-2011)Biosite Inc Dba Innovacon Inc.2010-11-22
Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed qua recall (Z-0442-2011)Biosite Inc Dba Innovacon Inc.2010-11-22
Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. To be used for recall (Z-0443-2011)Biosite Inc Dba Innovacon Inc.2010-11-22

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Every clearance here is in the API, with alerts when new ones post.