FDA 510(k) Applications Submitted by CAREY A MAYO
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K041799 |
07/02/2004 |
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS |
Ortho-Clinical Diagnostics, Inc. |
K041764 |
06/30/2004 |
THE VITROS 5,1 FS CHEMISTRY SYSTEM |
ORTHO-CLINICAL DIAGNOSTICS |
K042476 |
09/13/2004 |
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS |
Ortho-Clinical Diagnostics, Inc. |
K042479 |
09/13/2004 |
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE |
Ortho-Clinical Diagnostics, Inc. |
K042520 |
09/16/2004 |
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
K043384 |
12/09/2004 |
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
K043386 |
12/09/2004 |
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
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