FDA 510(k) Premarket Notification K854087: NML TSH IRMA

Submission Details & Decision

Normalized public record details for 510(k) notification K854087.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K854087

Applicant / Sponsor

Organon Teknika Corp.

Device Name

NML TSH IRMA

Product Code

JLW

Decision Date

1985-10-25

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1985-10-07

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