LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208— 510(k) K984479

Name: FDA 510(k) clearance K984479
Creator: U.S. Food and Drug Administration
Published: 1998-12-22

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K984479 for LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208, Substantially Equivalent on 1998-12-22. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LKP
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1998-12-16
Decision date: 1998-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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