LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)— 510(k) K855057

Name: FDA 510(k) clearance K855057
Creator: U.S. Food and Drug Administration
Published: 1986-02-26

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K855057 for LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS), Substantially Equivalent on 1986-02-26. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 1985-12-18
Decision date: 1986-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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