ALKALINE PHOSPHATASE— 510(k) K812452

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K812452 for ALKALINE PHOSPHATASE, Substantially Equivalent on 1981-09-09. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1981-08-28
Decision date: 1981-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.