GO GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LXN BLOOD GLUCOSE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LXN FRUCTOSAMINE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

PERSONAL GLUCOSE CONTROL CHARTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LXN FRUCTOSAMINE TEST

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DUET II GLUCOSE CONTROL MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Ta Yuan Manufacturing Co., Ltd.

FDA registration

Zhong Shan Shi Luen Hing Tai Toys Factory Co., Ltd.·1 product·🇨🇳 China

Huizhou Xinghuayuan Houseware Co.,Ltd

FDA registration

Zhong Shan Shi Luen Hing Tai Toys Factory Co., Ltd.·1 product·🇨🇳 China

Leader Goggles

FDA registration

Haifeng Jinghui Plastic Toys Company Limited·1 product·🇨🇳 China

CARBON DIOXIDE L3K Assay

FDA UDI

SEKISUI DIAGNOSTICS, LLC·00628063400294·

CARBON DIOXIDE L3K Assay

FDA UDI

SEKISUI DIAGNOSTICS, LLC·00628063400287·

CARBON DIOXIDE L3K Assay

FDA UDI

SEKISUI DIAGNOSTICS, LLC·00628063400300·

CARBON DIOXIDE L3K Assay

FDA UDI

SEKISUI DIAGNOSTICS, LLC·00628063400317·

SEKURE Acetaminophen L3K Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Sensiband

FDA registration

HOPEFUL RUBBER MANUFACTURING CO.·1 product·🇭🇰 Hong Kong

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

LBK 1244 DELFIA HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GOLD GATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular