P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT— 510(k) K904761

Name: FDA 510(k) clearance K904761
Creator: U.S. Food and Drug Administration
Published: 1990-11-20

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K904761 for P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT, Substantially Equivalent on 1990-11-20. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code CIE
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1990-10-19
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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