FDA 510(k) Premarket Notification K821931: ZETA-CORT

Submission Details & Decision

Normalized public record details for 510(k) notification K821931.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K821931

Applicant / Sponsor

Amf Biological and Diagnostics Co.

Device Name

ZETA-CORT

Product Code

CGR

Decision Date

1982-07-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1982-06-29

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