AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)— 510(k) K023396

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K023396 for AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS), Substantially Equivalent on 2002-12-23. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CIJ
Advisory panel: Clinical Chemistry
Date received: 2002-10-09
Decision date: 2002-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

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