FDA 510(k) Premarket Notification K870259: VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044

Submission Details & Decision

Normalized public record details for 510(k) notification K870259.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K870259

Applicant / Sponsor

Leeco Diagnostics, Inc.

Device Name

VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044

Product Code

JHI

Decision Date

1987-03-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1987-01-23

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