I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS— 510(k) K945522

Name: FDA 510(k) clearance K945522
Creator: U.S. Food and Drug Administration
Published: 1994-12-12

Substantially Equivalent

Beckman-Diagnostic Systems Group

FDA 510(k) clearance K945522 for I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS, Substantially Equivalent on 1994-12-12. Applicant: Beckman-Diagnostic Systems Group. Device class: 2.

Clearance details

Applicant: Beckman-Diagnostic Systems Group
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1994-11-10
Decision date: 1994-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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