TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT— 510(k) K853069

Name: FDA 510(k) clearance K853069
Creator: U.S. Food and Drug Administration
Published: 1986-01-01

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K853069 for TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT, Substantially Equivalent on 1986-01-01. Applicant: Hybritech, Inc.. Device class: 2.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1985-07-22
Decision date: 1986-01-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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