ACCESS RUBELLA IGG— 510(k) K954687

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K954687 for ACCESS RUBELLA IGG, Substantially Equivalent on 1996-04-09. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1995-10-11
Decision date: 1996-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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