ALKALINE PHOSPHATASE TEST— 510(k) K771695

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K771695 for ALKALINE PHOSPHATASE TEST, Substantially Equivalent on 1977-10-18. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1977-09-06
Decision date: 1977-10-18
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.