POINTE 360— 510(k) K062118

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K062118 for POINTE 360, Substantially Equivalent on 2007-07-13. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 2006-07-25
Decision date: 2007-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

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