HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT— 510(k) K951967

Name: FDA 510(k) clearance K951967
Creator: U.S. Food and Drug Administration
Published: 1995-05-30

Substantially Equivalent

Kent Laboratories, Inc.

FDA 510(k) clearance K951967 for HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT, Substantially Equivalent on 1995-05-30. Applicant: Kent Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kent Laboratories, Inc.
Product code: Code DBA
Device class: Class 2
Regulation: 21 CFR 866.5250
Advisory panel: Immunology
Date received: 1995-04-27
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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