FDA 510(k) Premarket Notification K936212: GLUCOFILM TEST STRIPS

Submission Details & Decision

Normalized public record details for 510(k) notification K936212.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K936212

Applicant / Sponsor

Heraeus Kulzer, Inc.

Device Name

GLUCOFILM TEST STRIPS

Product Code

CGA

Decision Date

1994-05-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1993-12-28

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