SYLNELISA HISTONE ANTIBODIES— 510(k) K932302

Name: FDA 510(k) clearance K932302
Creator: U.S. Food and Drug Administration
Published: 1993-08-23

Substantially Equivalent

Elias U.S.A., Inc.

FDA 510(k) clearance K932302 for SYLNELISA HISTONE ANTIBODIES, Substantially Equivalent on 1993-08-23. Applicant: Elias U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Elias U.S.A., Inc.
Product code: Code LKJ
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1993-05-12
Decision date: 1993-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osceola, WI, US

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