FDA 510(k) Premarket Notification K821916: IMPROVED MEM-RICHTER'S POWDER MODIF.

Submission Details & Decision

Normalized public record details for 510(k) notification K821916.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K821916

Applicant / Sponsor

Dutchland Laboratories, Inc.

Device Name

IMPROVED MEM-RICHTER'S POWDER MODIF.

Product Code

KIT

Decision Date

1982-07-27

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

1982-06-28

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