IL TEST 97574-15M, ANTITTHROMBIN III ASSASY— 510(k) K864214

Name: FDA 510(k) clearance K864214
Creator: U.S. Food and Drug Administration
Published: 1986-11-25

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K864214 for IL TEST 97574-15M, ANTITTHROMBIN III ASSASY, Substantially Equivalent on 1986-11-25. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1986-10-28
Decision date: 1986-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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