FDA 510(k) Premarket Notification K910283: DANAM DATACELL-18

Submission Details & Decision

Normalized public record details for 510(k) notification K910283.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K910283

Applicant / Sponsor

Danam Electronics

Device Name

DANAM DATACELL-18

Product Code

GKZ

Decision Date

1991-04-12

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

1991-01-23

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