RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE— 510(k) K951359

Name: FDA 510(k) clearance K951359
Creator: U.S. Food and Drug Administration
Published: 1996-04-15

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K951359 for RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE, Substantially Equivalent on 1996-04-15. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1995-03-27
Decision date: 1996-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middletown, VA, US

Download summary PDF View on FDA.gov ↗

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