FDA 510(k) Applications Submitted by MARLENE SHULMAN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K001133 |
04/10/2000 |
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
| K001885 |
06/21/2000 |
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 |
Ortho-Clinical Diagnostics, Inc. |
| K993068 |
09/13/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS |
ORTHO-CLINICAL DIAGNOSTICS |
| K984303 |
12/02/1998 |
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT |
Ortho-Clinical Diagnostics, Inc. |
| K001310 |
04/25/2000 |
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 |
Ortho-Clinical Diagnostics, Inc. |
| K001679 |
06/01/2000 |
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 |
Ortho-Clinical Diagnostics, Inc. |
| K992349 |
07/14/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
| K992366 |
07/15/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK |
Ortho-Clinical Diagnostics, Inc. |
| K012593 |
08/10/2001 |
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
| K013899 |
11/23/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS |
ORTHO-CLINICAL DIAGNOSTICS |
| K013900 |
11/23/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
| K984288 |
12/01/1998 |
VITROS CHEMISTRY PRODUCTS PHBR SLIDES |
Ortho-Clinical Diagnostics, Inc. |
| K994145 |
12/08/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
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