FDA 510(k) Applications Submitted by ANNE ZAVERTNIK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990016 |
01/04/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
| K990026 |
01/05/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
| K990061 |
01/08/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
| K990531 |
02/19/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
| K990783 |
03/09/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
| K990943 |
03/22/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK |
Ortho-Clinical Diagnostics, Inc. |
| K990984 |
03/24/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
| DEN180017 |
04/02/2018 |
Quantra Hemostasis Analyzer, QPlus Cartridge |
HemoSonics, LLC |
| K050948 |
04/15/2005 |
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
| K201513 |
06/08/2020 |
Quantra QPlus System |
HemoSonics, LLC |
| K012155 |
07/11/2001 |
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS |
EASTMAN KODAK COMPANY |
| K983031 |
08/31/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY |
Ortho-Clinical Diagnostics, Inc. |
| K983507 |
10/07/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY |
Ortho-Clinical Diagnostics, Inc. |
| K983513 |
10/07/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
| K983674 |
10/20/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
| K983690 |
10/21/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK |
Ortho-Clinical Diagnostics, Inc. |
| K983875 |
11/02/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK |
Ortho-Clinical Diagnostics, Inc. |
| K983990 |
11/09/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY |
Ortho-Clinical Diagnostics, Inc. |
| K984011 |
11/10/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
| K984166 |
11/20/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 |
Ortho-Clinical Diagnostics, Inc. |
| K984289 |
12/01/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK |
Ortho-Clinical Diagnostics, Inc. |
| K984321 |
12/03/1998 |
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS |
Ortho-Clinical Diagnostics, Inc. |
|
|
