FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

107 results for "Ortho-Clinical Diagnostics, Inc."

97–107 of 107

Search insights Median review: 56d Cleared: 98% Top manufacturer: Ortho-Clinical Diagnostics, Inc. Lead specialty: Chemistry

Cleared Jan 28, 1999

VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT

Ortho-Clinical Diagnostics, Inc.

Chemistry · 57d

Cleared Jan 26, 1999

VITROS CHEMISTRY PRODUCTS PHBR SLIDES

Ortho-Clinical Diagnostics, Inc.

Toxicology · 56d

Cleared Jan 25, 1999

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS

Ortho-Clinical Diagnostics, Inc.

Chemistry · 17d

Cleared Jan 22, 1999

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

Ortho-Clinical Diagnostics, Inc.

Immunology · 50d

Cleared Dec 29, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY

Ortho-Clinical Diagnostics, Inc.

Chemistry · 50d

Cleared Dec 18, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY

Ortho-Clinical Diagnostics, Inc.

Immunology · 109d

Cleared Dec 07, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS

Ortho-Clinical Diagnostics, Inc.

Chemistry · 27d

Cleared Nov 04, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY

Ortho-Clinical Diagnostics, Inc.

Chemistry · 28d

Cleared Nov 03, 1998

VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS

Ortho-Clinical Diagnostics, Inc.

Chemistry · 27d

Cleared Aug 12, 1998

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

Ortho-Clinical Diagnostics, Inc.

Chemistry · 13d

Cleared Oct 22, 1997

VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN...

Ortho-Clinical Diagnostics, Inc.

Immunology · 48d