ALKALINE PHOSPHATASE REAGENT SET— 510(k) K880307

Name: FDA 510(k) clearance K880307
Creator: U.S. Food and Drug Administration
Published: 1988-03-15

Substantially Equivalent

Tech-Neal Scientific, Inc.

FDA 510(k) clearance K880307 for ALKALINE PHOSPHATASE REAGENT SET, Substantially Equivalent on 1988-03-15. Applicant: Tech-Neal Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Neal Scientific, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1988-01-25
Decision date: 1988-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, 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.