Medical Device Manufacturer · US , Redmond , WA

Biotope, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1991

7

Total

7

Cleared

0

Denied

Biotope, Inc. has 7 FDA 510(k) cleared medical devices. Based in Redmond, US.

Historical record: 7 cleared submissions from 1991 to 1991. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Biotope, Inc. Filter by specialty or product code using the sidebar.

7 devices

1–7 of 7

ECLIPSE ICA CHOLESTEROL

K905145 · CHH Enzymatic Esterase--oxidase, Cholesterol · Chemistry

ECLIPSE ICA TSH

K910256 · JLW Radioimmunoassay, Thyroid-stimulating Hormone · Chemistry

ECLIPSE ICA ANALYZER

K910302 · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use · Chemistry

ECLIPSE ICA TRIGLYCERIDES

K905601 · CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides · Chemistry

ECLIPSE ICA DIGOXIN

K905719 · DPO Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. · Toxicology

ECLIPSE ICA BUN

K905602 · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen · Chemistry

ECLIPSE ICA GLUCOSE

K905144 · CFR Hexokinase, Glucose · Chemistry