FDA 510(k) Applications Submitted by SARAH CV PARSONS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K063720 |
12/15/2006 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
| K030067 |
01/07/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS |
ORTHO-CLINICAL DIAGNOSTICS |
| K060678 |
03/14/2006 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
| K060770 |
03/22/2006 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
| K041322 |
05/18/2004 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
| K032993 |
09/25/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
| K033127 |
09/30/2003 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS |
ORTHO-CLINICAL DIAGNOSTICS |
| K163628 |
12/22/2016 |
Idylla Respiratory (IFV-RSV) Panel |
JANSSEN PHARMACEUTICA NV |
| K063144 |
10/16/2006 |
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM |
Ortho-Clinical Diagnostics, Inc. |
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