IL TEST(TM) HAPTOGLOBIN (HPT)— 510(k) K915829

Name: FDA 510(k) clearance K915829
Creator: U.S. Food and Drug Administration
Published: 1992-07-29

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K915829 for IL TEST(TM) HAPTOGLOBIN (HPT), Substantially Equivalent on 1992-07-29. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code DAD
Device class: Class 2
Regulation: 21 CFR 866.5460
Advisory panel: Immunology
Date received: 1991-12-30
Decision date: 1992-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

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