Medical Device Manufacturer · US , Mountain View , CA

Hitachi Chemical Diagnostics, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2003

Recent clearances: Allergen-Specific IgE Assay 12 Allergen Bundle, AP3600 Automated Instrument

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hitachi Chemical Diagnostics, Inc. Immunology ✕

6 devices

1-6 of 6

Cleared Oct 18, 2021

Allergen-Specific IgE Assay 12 Allergen Bundle

Immunology · 662d

Cleared Mar 19, 2019

AP3600 Automated Instrument

Immunology · 169d

Cleared Dec 20, 2012

AP 72OS SEMI-AUTOMATED INSTRUMENT

Immunology · 444d

Cleared Aug 17, 2012

HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)

Immunology · 238d

Cleared Jan 23, 2006

OPTIGEN ALLERGEN SPECIFIC IGE ASSAY

Immunology · 216d

Cleared Mar 21, 2003

CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)

Immunology · 24d