BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM— 510(k) K872845

Name: FDA 510(k) clearance K872845
Creator: U.S. Food and Drug Administration
Published: 1987-08-17

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K872845 for BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM, Substantially Equivalent on 1987-08-17. Applicant: Bion Ent., Ltd.. Device class: 2.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-07-20
Decision date: 1987-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

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