FDA 510(k) Premarket Notification K850376: TERUMO SENSIBEAD EIA TSH KIT

Submission Details & Decision

Normalized public record details for 510(k) notification K850376.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K850376

Applicant / Sponsor

Terumo Medical Corp.

Device Name

TERUMO SENSIBEAD EIA TSH KIT

Product Code

JLW

Decision Date

1985-03-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1985-01-31

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