IMMOPHASE TM HPL RADIOIMMUNOASSAY— 510(k) K823292

Name: FDA 510(k) clearance K823292
Creator: U.S. Food and Drug Administration
Published: 1982-12-28

Substantially Equivalent

Corning Medical & Scientific

FDA 510(k) clearance K823292 for IMMOPHASE TM HPL RADIOIMMUNOASSAY, Substantially Equivalent on 1982-12-28. Applicant: Corning Medical & Scientific. Device class: 2.

Clearance details

Applicant: Corning Medical & Scientific
Product code: Code JMF
Device class: Class 2
Regulation: 21 CFR 862.1585
Advisory panel: Clinical Chemistry
Date received: 1982-11-05
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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