Ortho-Clinical Diagnostics, Inc. - FDA 510(k) Cleared Devices

Cleared Sep 29, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

K031031 · MMI

Chemistry · 181d

Cleared Aug 13, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS

K032296 · JIS

Chemistry · 19d

Cleared Dec 10, 2002

VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4

K023875 · CIX

Chemistry · 19d

Cleared Aug 30, 2001

VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY...

K012593 · LBR

Chemistry · 20d

Cleared Jul 20, 2000

VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS...

K001885 · CDN

Chemistry · 29d

Cleared Jun 28, 2000

VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3

K001679 · CIT

Chemistry · 27d

Cleared May 05, 2000

VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR...

K001310 · JFY

Chemistry · 10d

Cleared May 02, 2000

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE...

K001266 · CGN

Chemistry · 12d

Cleared Apr 24, 2000

VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2

K001133 · KHS

Chemistry · 14d

Cleared Dec 22, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS...

K994145 · JIS

Chemistry · 14d

Cleared Oct 08, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK

K992366 · MMI

Chemistry · 85d

Cleared Aug 24, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS

K992349 · JJY

Chemistry · 41d

Cleared Mar 12, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS

K990531 · JJY

Chemistry · 21d

Cleared Feb 05, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS...

K984166 · CGN

Chemistry · 77d

Cleared Jan 29, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX...

K983674 · JMM

Chemistry · 101d

Cleared Jan 28, 1999

VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT

K984303 · LBR

Chemistry · 57d

Cleared Jan 25, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS

K990061 · JJX

Chemistry · 17d

Cleared Dec 29, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY

K983990 · CGR

Chemistry · 50d

Cleared Dec 07, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS

K984011 · JJX

Chemistry · 27d

Cleared Nov 04, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY

K983507 · JJY

Chemistry · 28d

Cleared Nov 03, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS

K983513 · JJY

Chemistry · 27d

Cleared Aug 12, 1998

VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III

K982649 · DIF

Chemistry · 13d