FDA 510(k) Premarket Notification K803039: PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.

Submission Details & Decision

Normalized public record details for 510(k) notification K803039.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K803039

Applicant / Sponsor

General Diagnostics

Device Name

PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.

Product Code

DIF

Decision Date

1980-12-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

1980-12-01

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