PSI AMYLASE REAGENT— 510(k) K864464

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K864464 for PSI AMYLASE REAGENT, Substantially Equivalent on 1987-01-21. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1986-11-12
Decision date: 1987-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

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