IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER— 510(k) K905215

Name: FDA 510(k) clearance K905215
Creator: U.S. Food and Drug Administration
Published: 1991-01-11

Substantially Equivalent

Cirrus Diagnostics, Inc.

FDA 510(k) clearance K905215 for IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER, Substantially Equivalent on 1991-01-11. Applicant: Cirrus Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Cirrus Diagnostics, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1990-11-20
Decision date: 1991-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.