FDA 510(k) Premarket Notification K811566: C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT

Submission Details & Decision

Normalized public record details for 510(k) notification K811566.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K811566

Applicant / Sponsor

Immuno Nuclear Corp.

Device Name

C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT

Product Code

CEW

Decision Date

1981-06-25

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1981-06-04

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