IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00— 510(k) K942687

Name: FDA 510(k) clearance K942687
Creator: U.S. Food and Drug Administration
Published: 1995-01-25

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K942687 for IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00, Substantially Equivalent on 1995-01-25. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1994-06-07
Decision date: 1995-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

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