FDA 510(k) Premarket Notification K832690: MINIMUM ESSENTIAL MED. EAGLE M0268

Submission Details & Decision

Normalized public record details for 510(k) notification K832690.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K832690

Applicant / Sponsor

Sigma Chemical Co.

Device Name

MINIMUM ESSENTIAL MED. EAGLE M0268

Product Code

KIT

Decision Date

1983-09-12

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

1983-08-04

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