SKI 5000— 510(k) K812646

Substantially Equivalent

Smithkline Diagnostics, Inc.

FDA 510(k) clearance K812646 for SKI 5000, Substantially Equivalent on 1981-11-16. Applicant: Smithkline Diagnostics, Inc..

Clearance details

Applicant: Smithkline Diagnostics, Inc.
Product code: Code DXK
Advisory panel: Cardiovascular
Date received: 1981-09-17
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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